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Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)
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Point in time view as at 22/08/2014.
There are currently no known outstanding effects for the Regulation (EC) No 1907/2006 of the European Parliament and of the Council.
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Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).
Textual Amendments
F1Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
Thus the information to be considered includes information related to the hazards of the substance, the exposure arising from the manufacture or import, the identified uses of the substance, operational conditions and risk management measures applied or recommended to downstream users to be taken into account.
In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information, because risk management measures and operational conditions which are necessary to control a well-characterised risk may also be sufficient to control other potential risks, which will not therefore need to be characterised precisely.
If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored.
Human health hazard assessment.
Human health hazard assessment of physicochemical properties.
Environmental hazard assessment.
PBT and vPvB assessment.
Exposure assessment.
The generation of exposure scenario(s) (or the identification of relevant use and exposure categories, if appropriate).
Exposure estimation.
Risk characterisation.
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, and 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;
hazard class 4.1;
hazard class 5.1.
Textual Amendments
An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.
If the substance is placed on the market, the relevant exposure scenario(s), including the risk management measures and operational conditions shall be included in an annex to the safety data sheet in accordance with Annex II.
acute effects such as acute toxicity, irritation and corrosivity;
sensitisation;
repeated dose toxicity; and
CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction).
Based on all the available information, other effects shall be considered when necessary.]
:
Evaluation of non-human information.
:
Evaluation of human information.
:
Classification and Labelling.
:
Derivation of DNELs.
the hazard identification for the effect based on all available non-human information,
the establishment of the quantitative dose (concentration)-response (effect) relationship.
If no human information is available, this part shall contain the statement: ‘ No human information is available ’ . However, if human information is available, it shall be presented, if possible in the form of a table.
The assessment should always include a statement as to whether the substance fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.
the uncertainty arising, among other factors, from the variability in the experimental information and from intra- and inter-species variation;
the nature and severity of the effect;
the sensitivity of the human (sub-)population to which the quantitative and/or qualitative information on exposure applies.
explosivity,
flammability,
oxidising potential.
If the information is inadequate to decide whether a substance should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.]
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Evaluation of information.
:
Classification and Labelling.
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Derivation of the PNEC.
the hazard identification based on all available information,
the establishment of the quantitative dose (concentration)-response (effect) relationship.
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Comparison with the Criteria.
:
Emission Characterisation.
The assessment shall also be summarised in the Safety Data Sheet under heading 12.
This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.
If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance.]
The objective of the exposure assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:
:
Generation of exposure scenario(s) or the generation of relevant use and exposure categories.
:
Exposure Estimation.
Where required and in accordance with Article 31, the exposure scenario shall also be included in an annex to the Safety Data Sheet.
The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of the use, consistent with those given in Section 3.5 of Annex VI. Exposure scenarios shall cover any manufacture in the Community and all identified uses.
In particular, an exposure scenario includes, where relevant, a description of:
Operational conditions
the processes involved, including the physical form in which the substance is manufactured, processed and/or used,
the activities of workers related to the processes and the duration and frequency of their exposure to the substance,
the activities of consumers and the duration and frequency of their exposure to the substance,
the duration and frequency of emissions of the substance to the different environmental compartments and sewage treatment systems and the dilution in the receiving environmental compartment.
Risk management measures
the risk management measures to reduce or avoid direct and indirect exposure of humans (including workers and consumers) and the different environmental compartments to the substance,
the waste management measures to reduce or avoid exposure of humans and the environment to the substance during waste disposal and/or recycling.
adequately measured, representative exposure data,
any major impurities and additives in the substance,
the quantity in which the substance is produced and/or imported,
the quantity for each identified use,
implemented or recommended risk management, including the degree of containment,
duration and frequency of exposure according to the operational conditions,
the activities of workers related to the processes and the duration and frequency of their exposure to the substance,
the activities of consumers and the duration and frequency of their exposure to the substance,
the duration and frequency of emissions of the substance to the different environmental compartments and the dilution in the receiving environmental compartment,
the physicochemical properties of the substance,
transformation and/or degradation products,
the likely routes of exposure of and potential for absorption in humans,
the likely pathways to the environment and environmental distribution and degradation and/or transformation (see also Section 3 Step 1),
scale (geographical) of exposure,
matrix dependent release/migration of the substance.
a comparison of the exposure of each human population known to be or likely to be exposed with the appropriate DNEL,
a comparison of the predicted environmental concentrations in each environmental sphere with the PNECs, and
an assessment of the likelihood and severity of an event occurring due to the physicochemical properties of the substance.
the exposure levels estimated in Section 6.2 do not exceed the appropriate DNEL or the PNEC, as determined in Sections 1 and 3, respectively, and,
the likelihood and severity of an event occurring due to the physicochemical properties of the substance as determined in Section 2 is negligible.
For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle of the substance that results from manufacture or identified uses.
The Chemical Safety Report shall include the following headings:
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Textual Amendments
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(etc.)
(etc.)
10.x.1.1.
10.x.2.1.
Textual Amendments
The information required by this Annex shall be included in the safety data sheet, where applicable and available, in the relevant subsections set out in Part B. The safety data sheet shall not contain blank subsections.
The inclusion of additional relevant and available information in the relevant subsections may be necessary in some cases in view of the wide range of properties of substances and mixtures.
The units of measurement as set out in Council Directive 80/181/EEC (2) shall be used.
Safety data sheets shall also be required for the special cases listed in paragraph 1.3 of Annex I to Regulation (EC) No 1272/2008 for which there are labelling derogations.
This section prescribes how the substance or mixture shall be identified and how the identified relevant uses, the name of the supplier of the substance or mixture and the contact detail information of the supplier of the substance or mixture including an emergency contact shall be provided in the safety data sheet.
In the case of a substance, the product identifier shall be provided in accordance with Article 18(2) of Regulation (EC) No 1272/2008 and as provided on the label in the official language(s) of the Member State(s) where the substance is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
For substances subject to registration, the product identifier shall be consistent with that provided in the registration and the registration number assigned under Article 20(3) of this Regulation shall also be indicated.
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by a supplier who is a distributor or a downstream user provided that:
this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and
this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the enforcement authority) within 7 days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within 7 days upon request and at the same time inform the enforcement authority thereof.
In the case of a mixture, the trade name or designation shall be provided in accordance with Article 10(2.1) of Directive 1999/45/EC.
A single safety data sheet may be provided to cover more than one substance or mixture where the information in that safety data sheet fulfils the requirements of this Annex for each of those substances or mixtures.
Other names or synonyms by which the substance or mixture is labelled or commonly known, such as alternative names, numbers, company product codes, or other unique identifiers may be provided.
At least the identified uses relevant for the recipient(s) of the substance or mixture shall be indicated. This shall be a brief description of what the substance or mixture is intended to do, such as ‘ flame retardant ’ , ‘ antioxidant ’ .
The uses which the supplier advises against and why shall, where applicable, be stated. This need not be an exhaustive list.
Where a chemical safety report is required, the information in this subsection of the safety data sheet shall be consistent with the identified uses in the chemical safety report and the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet.
The supplier, whether it is the manufacturer, importer, only representative, downstream user or distributor, shall be identified. The full address and telephone number of the supplier shall be given as well as an e-mail address for a competent person responsible for the safety data sheet.
In addition, if the supplier is not located in the Member State where the substance or mixture is placed on the market and he has nominated a responsible person for that Member State, a full address and telephone number for that responsible person shall be given.
For registrants, the information shall be consistent with the information on the identity of the manufacturer or importer provided in the registration.
Where an only representative has been appointed, details of the non-Community manufacturer or formulator may also be provided.
References to emergency information services shall be provided. If an official advisory body exists in the Member State where the substance or mixture is placed on the market (this may be the body responsible for receiving information relating to health referred to in Article 45 of Regulation (EC) No 1272/2008 and Article 17 of Directive 1999/45/EC), its telephone number shall be given and can suffice. If availability of such services is limited for any reasons, such as hours of operation, or if there are limits on specific types of information provided, this shall be clearly stated.
This section of the safety data sheet shall describe the hazards of the substance or mixture and the appropriate warning information associated with those hazards.
In the case of a substance, the classification which arises from the application of the classification rules in Regulation (EC) No 1272/2008 shall be given. Where the supplier has notified information regarding the substance to the classification and labelling inventory in accordance with Article 40 of Regulation (EC) No 1272/2008, the classification given in the safety data sheet shall be the same as the classification provided in that notification.
The classification of the substance according to Directive 67/548/EEC shall also be given.
In the case of a mixture, the classification which arises from the application of the classification rules in Directive 1999/45/EC shall be given. If the mixture does not meet the criteria for classification in accordance with Directive 1999/45/EC, this shall be clearly stated. Information on the substances in the mixture is provided under subsection 3.2.
If the classification, including the hazard statements and R phrases, is not written out in full, reference shall be made to Section 16 where the full text of each classification, including each hazard statement and R phrase, shall be given.
The most important adverse physicochemical, human health and environmental effects shall be listed consistent with Sections 9 to 12 of the safety data sheet, in a way as to allow non-experts to identify the hazards of the substance or mixture.
In the case of a substance, based on the classification, at least the following elements appearing on the label in accordance with Regulation (EC) No 1272/2008 shall be provided: hazard pictogram(s), signal word(s), hazard statement(s) and precautionary statement(s). A graphical reproduction of the full hazard pictogram in black and white or a graphical reproduction of the symbol only may be substituted for the colour pictogram provided in Regulation (EC) No 1272/2008.
In the case of a mixture, based on the classification, at least the appropriate symbol(s), indication(s) of danger, risk phrase(s) and safety advice appearing on the label in accordance with Directive 1999/45/EC shall be provided. The symbol may be provided as a graphical reproduction of the symbol in black and white.
The applicable label elements in accordance with Article 25 and Article 32(6) of Regulation (EC) No 1272/2008, in the case of a substance, or Sections A and B of Annex V to Directive 1999/45/EC, in the case of a mixture, shall be provided.
Information on whether the substance or mixture meets the criteria for PBT or vPvB in accordance with Annex XIII shall be provided.
Information shall be provided on other hazards which do not result in classification but which may contribute to the overall hazards of the substance or mixture, such as formation of air contaminants during hardening or processing, dustiness, dust explosion hazards, cross-sensitisation, suffocation, freezing, high potency for odour or taste, or environmental effects like hazards to soil-dwelling organisms, or photochemical ozone creation potential.
This section of the safety data sheet shall describe the chemical identity of the ingredient(s) of the substance or mixture, including impurities and stabilising additives as set out below. Appropriate and available safety information on surface chemistry shall be indicated.
The chemical identity of the main constituent of the substance shall be provided by providing at least the product identifier or one of the other means of identification given in subsection 1.1.
The chemical identity of any impurity, stabilising additive, or individual constituent other than the main constituent, which is itself classified and which contributes to the classification of the substance shall be provided as follows:
the product identifier in accordance with Article 18(2) of Regulation (EC) No 1272/2008;
if the product identifier is not available, one of the other names (usual name, trade name, abbreviation) or identification numbers.
Suppliers of substances may choose to list in addition all constituents including non-classified ones.
This subsection may also be used to provide information on multi-constituent substances.
The product identifier when available, concentration or concentration ranges and classifications shall be provided for at least all substances referred to in points 3.2.1 or 3.2.2. Suppliers of mixtures may choose to list in addition all substances in the mixture, including substances not meeting the criteria for classification. This information shall enable the recipient to identify readily the hazards of the substances in the mixture. The hazards of the mixture itself shall be given in Section 2.
The concentrations of the substances in a mixture shall be described as either of the following:
exact percentages in descending order by mass or volume, if technically possible;
ranges of percentages in descending order by mass or volume, if technically possible.
When using a range of percentages, the health and environmental hazards shall describe the effects of the highest concentration of each ingredient.
If the effects of the mixture as a whole are available, this information shall be included under Section 2.
Where the use of an alternative chemical name has been allowed under Article 15 of Directive 1999/45/EC or under Article 24 of Regulation (EC) No 1272/2008, that name can be used.
substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC and substances presenting a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008, provided that information complying with the classification criteria of that Regulation has been made available to the supplier of the mixture, if those substances are present in concentrations equal to or greater than the lowest of any of the following:
the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC;
the specific concentration limits given in Part 3 of Annex VI to Regulation (EC) No 1272/2008;
if an M-factor has been given in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation;
the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
the concentration limits given in Annex V to Directive 1999/45/EC;
the specific concentration limits provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008;
if an M-factor has been provided to the classification and labelling inventory established under Regulation (EC) No 1272/2008, the generic cut-off value in Table 1.1 of Annex I to that Regulation, adjusted using the calculation set out in Section 4.1 of Annex I to that Regulation.
substances for which there are Community workplace exposure limits, which are not already included under point (a);
substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or substances included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a), if the concentration of an individual substance is equal to or greater than 0,1 %.
1 % by weight in non-gaseous mixtures and 0,2 % by volume in gaseous mixtures for
substances which present a health or environmental hazard within the meaning of Directive 67/548/EEC and substances which present a health or environmental hazard within the meaning of Regulation (EC) No 1272/2008, provided that information complying with the classification criteria of that Regulation has been made available to the supplier of the mixture; or
substances which are assigned Community workplace exposure limits;
0,1 % by weight for substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII, very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or included in the list established in accordance with Article 59(1) for reasons other than the hazards referred to in point (a).
Without affecting the obligations of downstream users laid down in Article 39 of this Regulation, the part of the registration number referring to the individual registrant of a joint submission may be omitted by the supplier of the mixture provided that:
this supplier assumes the responsibility to provide the full registration number upon request for enforcement purposes, or, if the full registration number is not available to him, to forward the request to his supplier, in line with point (b); and
this supplier provides the full registration number to the Member State authority responsible for enforcement (hereinafter referred to as the enforcement authority) within 7 days upon request, received either directly from the enforcement authority or forwarded by his recipient, or, if the full registration number is not available to him, this supplier shall forward the request to his supplier within 7 days upon request and at the same time inform the enforcement authority thereof.
The EC number, if available, shall be given in accordance with Regulation (EC) No 1272/2008. The CAS number, if available, and IUPAC name, if available, may also be given.
For substances indicated in this subsection by means of an alternative chemical name in accordance with Article 15 of Directive 1999/45/EC or Article 24 of Regulation (EC) No 1272/2008, the registration number, EC number and other precise chemical identifiers are not necessary.
This section of the safety data sheet shall describe the initial care in such a way that it can be understood and given by an untrained responder without the use of sophisticated equipment and without the availability of a wide selection of medications. If medical attention is required, the instructions shall state this, including its urgency.
immediate medical attention is required and if delayed effects can be expected after exposure;
movement of the exposed individual from the area to fresh air is recommended;
removal and handling of clothing and shoes from the individual is recommended; and
personal protective equipment for first aid responders is recommended.
Briefly summarised information shall be provided on the most important symptoms and effects, both acute and delayed, from exposure.
Where appropriate, information shall be provided on clinical testing and medical monitoring for delayed effects, specific details on antidotes (where they are known) and contraindications.
For some substances or mixtures, it may be important to emphasise that special means to provide specific and immediate treatment shall be available at the workplace.
This section of the safety data sheet shall describe the requirements for fighting a fire caused by the substance or mixture, or arising in its vicinity.
Suitable extinguishing media:
Information shall be provided on the appropriate extinguishing media.
Unsuitable extinguishing media:
Indications shall be given whether any extinguishing media are inappropriate for a particular situation involving the substance or mixture.
Information shall be provided on hazards that may arise from the substance or mixture, like hazardous combustion products that form when the substance or mixture burns, such as ‘ may produce toxic fumes of carbon monoxide if burning ’ or ‘ produces oxides of sulphur and nitrogen on combustion ’ .
Advice shall be provided on any protective actions to be taken during firefighting, such as ‘ keep containers cool with water spray ’ , and on special protective equipment for firefighters, such as boots, overalls, gloves, eye and face protection and breathing apparatus.
This section of the safety data sheet shall recommend the appropriate response to spills, leaks, or releases, to prevent or minimise the adverse effects on persons, property and the environment. It shall distinguish between responses to large and small spills, in cases where the spill volume has a significant impact on the hazard. If the procedures for containment and recovery indicate that different practices are required, these shall be indicated in the safety data sheet.
Advice shall be provided related to accidental spills and release of the substance or mixture such as:
the wearing of suitable protective equipment (including personal protective equipment referred to under Section 8 of the safety data sheet) to prevent any contamination of skin, eyes and personal clothing;
removal of ignition sources, provision of sufficient ventilation, control of dust; and
emergency procedures such as the need to evacuate the danger area or to consult an expert.
Advice shall be provided related to suitable fabric for personal protective clothing (such as ‘ appropriate: Butylene ’ ; ‘ not appropriate: PVC ’ ).
Advice shall be provided on any environmental precautions to be taken related to accidental spills and release of the substance or mixture, such as keeping away from drains, surface and ground water.
bunding, covering of drains;
capping procedures.
neutralisation techniques;
decontamination techniques;
adsorbent materials;
cleaning techniques;
vacuuming techniques;
equipment required for containment/clean-up (include the use of non-sparking tools and equipment where applicable).
If appropriate Sections 8 and 13 shall be referred to.
This section of the safety data sheet shall provide advice on safe handling practices. It shall emphasise precautions that are appropriate to the identified uses referred to under subsection 1.2 and to the unique properties of the substance or mixture.
Information in this section of the safety data sheet shall relate to the protection of human health, safety and the environment. It shall assist the employer in devising suitable working procedures and organisational measures according to Article 5 of Directive 98/24/EC and Article 5 of Directive 2004/37/EC of the European Parliament and of the Council.
Where a chemical safety report is required, the information in this section of the safety data sheet shall be consistent with the information given for the identified uses in the chemical safety report and the exposure scenarios showing control of risk from the chemical safety report set out in the annex to the safety data sheet.
In addition to information given in this section, relevant information may also be found in Section 8.
allow safe handling of the substance or mixture, such as containment and measures to prevent fire as well as aerosol and dust generation;
prevent handling of incompatible substances or mixtures; and
reduce the release of the substance or mixture to the environment, such as avoiding spills or keeping away from drains.
not to eat, drink and smoke in work areas;
to wash hands after use; and
to remove contaminated clothing and protective equipment before entering eating areas.
The advice provided shall be consistent with the physical and chemical properties described in Section 9 of the safety data sheet. If relevant, advice shall be provided on specific storage requirements including:
how to manage risks associated with:
explosive atmospheres;
corrosive conditions;
flammability hazards;
incompatible substances or mixtures;
evaporative conditions; and
potential ignition sources (including electrical equipment);
how to control the effects of:
weather conditions;
ambient pressure;
temperature;
sunlight;
humidity; and
vibration;
how to maintain the integrity of the substance or mixture by the use of:
stabilisers; and
antioxidants;
other advice including:
ventilation requirements;
specific designs for storage rooms or vessels (including retention walls and ventilation);
quantity limits under storage conditions (if relevant); and
packaging compatibilities.
For substances and mixtures designed for specific end use(s), recommendations shall relate to the identified use(s) referred to in subsection 1.2 and be detailed and operational. If an exposure scenario is attached, reference to it may be made or the information as required in subsections 7.1 and 7.2 shall be provided. If an actor in the supply chain has carried out a chemical safety assessment for the mixture, it is sufficient that the safety data sheet and the exposure scenarios are consistent with the chemical safety report for the mixture instead of with the chemical safety reports for each substance in the mixture. If industry or sector specific guidance is available, detailed reference to it (including source and issuing date) may be made.
This section of the safety data sheet shall describe the applicable occupational exposure limits and necessary risk management measures.
Where a chemical safety report is required, the information in this section of the safety data sheet shall be consistent with the information given for the identified uses in the chemical safety report and the exposure scenarios showing control of risk from the chemical safety report set out in the annex to the safety data sheet.
the national occupational exposure limit values that correspond to Community occupational exposure limit values in accordance with Directive 98/24/EC, including any notations as referred to in Article 2(1) of Commission Decision 95/320/EC (3) ;
the national occupational exposure limit values that correspond to Community limit values in accordance with Directive 2004/37/EC, including any notations as referred to in Article 2(1) of Decision 95/320/EC;
any other national occupational exposure limit values;
the national biological limit values that correspond to Community biological limit values in accordance with Directive 98/24/EC, including any notations as referred to in Article 2(1) of Decision 95/320/EC;
any other national biological limit values.
The information required in the present subsection shall be provided, unless an exposure scenario containing that information is attached to the safety data sheet.
Where the supplier has waived a test under Section 3 of Annex XI, he shall indicate the specific conditions of use relied on to justify the waiving.
Where a substance has been registered as an isolated intermediate (on-site or transported), the supplier shall indicate that this safety data sheet is consistent with the specific conditions relied on to justify the registration in accordance with Article 17 or 18.
The description of appropriate exposure control measures shall relate to the identified use(s) of the substance or mixture as referred to in subsection 1.2. This information shall be sufficient to enable the employer to carry out an assessment of risk to the safety and health of workers arising from the presence of the substance or mixture in accordance with Articles 4 to 6 of Directive 98/24/EC as well as in accordance with Articles 3 to 5 of Directive 2004/37/EC, where appropriate.
This information shall complement that already given under Section 7.
Eye/face protection
The type of eye/face protection equipment required shall be specified based on the hazard of the substance or mixture and potential for contact, such as safety glasses, safety goggles, face-shield.
Skin protection
Hand protection
The type of gloves to be worn when handling the substance or mixture shall be clearly specified based on the hazard of the substance or mixture and potential for contact and with regard to the amount and duration of dermal exposure, including:
the type of material and its thickness,
the typical or minimum breakthrough times of the glove material.
If necessary any additional hand protection measures shall be indicated.
Other
If it is necessary to protect a part of the body other than the hands, the type and quality of protection equipment required shall be specified, such as gauntlets, boots, bodysuit based on the hazards associated with the substance or mixture and the potential for contact.
If necessary, any additional skin protection measures and specific hygiene measures shall be indicated.
Respiratory protection
For gases, vapours, mist or dust, the type of protective equipment to be used shall be specified based on the hazard and potential for exposure, including air-purifying respirators, specifying the proper purifying element (cartridge or canister), the adequate particulate filters and the adequate masks, or self-contained breathing apparatus.
Thermal hazards
When specifying protective equipment to be worn for materials that represent a thermal hazard, special consideration shall be given to the construction of the personal protective equipment.
The information required by the employer to fulfil his commitments under Community environmental protection legislation shall be specified.
Where a chemical safety report is required, a summary of the risk management measures that adequately control exposure of the environment to the substance shall be given for the exposure scenarios set out in the annex to the safety data sheet.
This section of the safety data sheet shall describe the empirical data relating to the substance or mixture, if relevant. The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.
The following properties shall be clearly identified including, where appropriate, a reference to the test methods used and specification of appropriate units of measurement and/or reference conditions. If relevant for the interpretation of the numerical value, the method of determination shall also be provided (for example, the method for flash point, the open-cup/closed-cup method):
Appearance:
The physical state (solid (including appropriate and available safety information on granulometry and specific surface area if not already specified elsewhere in this safety data sheet), liquid, gas) and the colour of the substance or mixture as supplied shall be indicated;
Odour:
If odour is perceptible, a brief description of it shall be given;
Odour threshold;
pH:
The pH shall be indicated of the substance or mixture as supplied or of an aqueous solution; in the latter case, the concentration shall be indicated;
Melting point/freezing point;
Initial boiling point and boiling range;
Flash point;
Evaporation rate;
Flammability (solid, gas);
Upper/lower flammability or explosive limits;
Vapour pressure;
Vapour density;
Relative density;
Solubility(ies);
Partition coefficient: n-octanol/water;
Auto-ignition temperature;
Decomposition temperature;
Viscosity;
Explosive properties;
Oxidising properties.
If it is stated that a particular property does not apply or if information on a particular property is not available, the reasons shall be given.
To enable proper control measures to be taken, all relevant information on the substance or mixture shall be provided. The information in this section shall be consistent with the information provided in a registration where one is required.
In the case of a mixture, the entries shall clearly indicate to which substance in the mixture the data apply, unless it is valid for the whole mixture.
Other physical and chemical parameters shall be indicated as necessary, such as miscibility, fat solubility (solvent — oil to be specified), conductivity, or gas group. Appropriate and available safety information on redox potential, radical formation potential and photocatalytic properties shall be indicated.
This section of the safety data sheet shall describe the stability of the substance or mixture and the possibility of hazardous reactions occurring under certain conditions of use and also if released into the environment, including, where appropriate, a reference to the test methods used. If it is stated that a particular property does not apply or if information on a particular property is not available, the reasons shall be given.
It shall be indicated if the substance or mixture is stable or unstable under normal ambient and anticipated storage and handling conditions of temperature and pressure. Any stabilisers which are, or may need to be, used to maintain the chemical stability of the substance or mixture shall be described. The safety significance of any change in the physical appearance of the substance or mixture shall be indicated.
If relevant, it shall be stated if the substance or mixture will react or polymerise, releasing excess pressure or heat, or creating other hazardous conditions. The conditions under which the hazardous reactions may occur shall be described.
Conditions such as temperature, pressure, light, shock, static discharge, vibrations or other physical stresses that might result in a hazardous situation shall be listed and if appropriate a brief description of measures to be taken to manage risks associated with such hazards shall be given.
Families of substances or mixtures or specific substances, such as water, air, acids, bases, oxidising agents, with which the substance or mixture could react to produce a hazardous situation (like an explosion, a release of toxic or flammable materials, or a liberation of excessive heat) shall be listed and if appropriate a brief description of measures to be taken to manage risks associated with such hazards shall be given.
Known and reasonably anticipated hazardous decomposition products produced as a result of use, storage, spill and heating shall be listed. Hazardous combustion products shall be included in Section 5 of the safety data sheet.
This section of the safety data sheet is meant for use primarily by medical professionals, occupational health and safety professionals and toxicologists. A concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects shall be provided, including where appropriate information on toxicokinetics, metabolism and distribution. The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.
acute toxicity;
skin corrosion/irritation;
serious eye damage/irritation;
respiratory or skin sensitisation;
germ cell mutagenicity;
carcinogenicity;
reproductive toxicity;
STOT-single exposure;
STOT-repeated exposure;
aspiration hazard.
acute toxicity;
irritation;
corrosivity;
sensitisation;
repeated dose toxicity;
carcinogenicity;
mutagenicity;
toxicity for reproduction.
Information shall be provided on likely routes of exposure and the effects of the substance or mixture via each possible route of exposure, that is, through ingestion (swallowing), inhalation or skin/eye exposure. If health effects are not known, this shall be stated.
Potential adverse health effects and symptoms associated with exposure to the substance or mixture and its ingredients or known by-products shall be described. Available information shall be provided on the symptoms related to the physical, chemical, and toxicological characteristics of the substance or mixture following exposure. The first symptoms at low exposures through to the consequences of severe exposure shall be described, such as ‘ headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death ’ .
Information shall be provided on whether delayed or immediate effects can be expected after short or long-term exposure. Information on acute and chronic health effects relating to human exposure to the substance or mixture shall also be provided. Where human data are not available, animal data shall be summarised and the species clearly identified. It shall be indicated whether toxicological data is based on human or animal data.
Information on interactions shall be included if relevant and available.
It may not always be possible to obtain information on the hazards of a substance or mixture. In cases where data on the specific substance or mixture are not available, data on similar substances or mixtures, if appropriate, may be used, provided the relevant similar substance or mixture is identified. Where specific data are not used, or where data are not available, this shall be clearly stated.
if the information is duplicated, it shall be listed only once for the mixture overall, such as when two substances both cause vomiting and diarrhoea;
if it is unlikely that these effects will occur at the concentrations present, such as when a mild irritant is diluted to below a certain concentration in a non-irritant solution;
where information on interactions between substances in a mixture is not available, assumptions shall not be made and instead the health effects of each substance shall be listed separately.
Other relevant information on adverse health effects shall be included even when not required by the classification criteria.
This section of the safety data sheet shall describe the information provided to evaluate the environmental impact of the substance or mixture where it is released to the environment. Under subsections 12.1 to 12.6 of the safety data sheet a short summary of the data shall be provided including, where available, relevant test data and clearly indicating species, media, units, test duration and test conditions. This information may assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measures and transport. If it is stated that a particular property does not apply or if information on a particular property is not available, the reasons shall be indicated.
Information on bioaccumulation, persistence and degradability shall be given, where available and appropriate, for each relevant substance in the mixture. Information shall also be provided for hazardous transformation products arising from the degradation of substances and mixtures.
The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.
Information on toxicity using data from tests performed on aquatic and/or terrestrial organisms shall be provided when available. This shall include relevant available data on aquatic toxicity, both acute and chronic for fish, crustaceans, algae and other aquatic plants. In addition, toxicity data on soil micro and macroorganisms and other environmentally relevant organisms, such as birds, bees and plants, shall be included when available. Where the substance or mixture has inhibitory effects on the activity of microorganisms, the possible impact on sewage treatment plants shall be mentioned.
For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI shall be included.
Persistence and degradability is the potential for the substance or the appropriate substances in a mixture to degrade in the environment, either through biodegradation or other processes such as oxidation or hydrolysis. Test results relevant to assess persistence and degradability shall be given where available. If degradation half-lives are quoted it must be indicated whether these half lives refer to mineralisation or to primary degradation. The potential of the substance or certain substances in a mixture to degrade in sewage treatment plants shall also be mentioned.
This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in Section 3 of the safety data sheet.
Bioaccumulative potential is the potential of the substance or certain substances in a mixture to accumulate in biota and, eventually, to pass through the food chain. Test results relevant to assess the bioaccumulative potential shall be given. This shall include reference to the octanol-water partition coefficient (Kow) and bioconcentration factor (BCF), if available.
This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in Section 3 of the safety data sheet.
Mobility in soil is the potential of the substance or the constituents of a mixture, if released to the environment, to move under natural forces to the groundwater or to a distance from the site of release. The potential for mobility in soil shall be given where available. Information on mobility can be determined from relevant mobility data such as adsorption studies or leaching studies, known or predicted distribution to environmental compartments, or surface tension. For example, Koc values can be predicted from octanol/water partition coefficients (Kow). Leaching and mobility can be predicted from models.
This information shall be given where available and appropriate, for each individual substance in the mixture which is required to be listed in Section 3 of the safety data sheet.
Where experimental data is available, that data shall, in general, take precedence over models and predictions.
Where a chemical safety report is required, the results of the PBT and vPvB assessment as set out in the chemical safety report shall be given.
Information on any other adverse effects on the environment shall be included where available, such as environmental fate (exposure), photochemical ozone creation potential, ozone depletion potential, endocrine disrupting potential and/or global warming potential.
This section of the safety data sheet shall describe information for proper waste management of the substance or mixture and/or its container to assist in the determination of safe and environmentally preferred waste management options, consistent with the requirements in accordance with Directive 2008/98/EC of the European Parliament and of the Council (5) of the Member State in which the safety data sheet is being supplied. Information relevant for the safety of persons conducting waste management activities shall complement the information given in Section 8.
Where a chemical safety report is required and where a waste stage analysis has been performed, the information on the waste management measures shall be consistent with the identified uses in the chemical safety report and the exposure scenarios from the chemical safety report set out in the annex to the safety data sheet.
Waste treatment containers and methods shall be specified including the appropriate methods of waste treatment of both the substance or mixture and any contaminated packaging (for example, incineration, recycling, landfilling);
Physical/chemical properties that may affect waste treatment options shall be specified;
Sewage disposal shall be discouraged;
Where appropriate, any special precautions for any recommended waste treatment option shall be identified.
Any relevant Community provisions relating to waste shall be referred to. In their absence any relevant national or regional provisions in force shall be referred to.
This section of the safety data sheet shall provide basic classification information for transporting/shipment of substances or mixtures mentioned under Section 1 by road, rail, sea, inland waterways or air. Where information is not available or relevant this shall be stated.
Where relevant, it shall provide information on the transport classification for each of the UN Model Regulations: European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) (6) , Regulations concerning the International Carriage of Dangerous Goods by Rail (RID) (7) , European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN) (8) , all three of which have been implemented by Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (9) , International Maritime Dangerous Goods (IMDG) Code (10) (sea), and Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO) (11) (air).
The UN number (i.e. the four-figure identification number of the substance, mixture or article preceded by the letters ‘ UN ’ ) from the UN Model Regulations shall be provided.
The UN proper shipping name from the UN Model Regulations shall be provided, unless it has appeared as the product identifier in subsection 1.1.
The transport hazard class (and subsidiary risks) assigned to the substances or mixtures according to the predominant hazard that they present in accordance with the UN Model Regulations shall be provided.
The packing group number from the UN Model Regulations shall be provided, if applicable. The packing group number is assigned to certain substances in accordance with their degree of hazard.
It shall be indicated whether the substance or mixture is environmentally hazardous according to the criteria of the UN Model Regulations (as reflected in the IMDG Code, ADR, RID and ADN) and/or a marine pollutant according to the IMDG Code. If authorised or intended for carriage by inland waterways in tank-vessels, it shall be indicated whether the substance or mixture is environmentally hazardous in tank-vessels only according to ADN.
Information shall be provided on any special precautions with which a user should or must comply or be aware of in connection with transport or conveyance either within or outside his premises.
This subsection only applies when cargoes are intended to be carried in bulk according to the following International Maritime Organisation (IMO) instruments: Annex II of the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 relating thereto (MARPOL 73/78) (12) and the International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk (International Bulk Chemical Code) (IBC Code) (13) .
The product name shall be provided (if different from that given in subsection 1.1) as required by the shipment document and in accordance with the name used in the lists of product names given in chapters 17 or 18 of the IBC Code or the latest edition of the IMO’s Marine Environment Protection Committee (MEPC).2/Circular (14) . Ship type required and pollution category shall be indicated.
This section of the safety data sheet shall describe the other regulatory information on the substance or mixture that is not already provided in the safety data sheet (such as whether the substance or mixture is subject to Regulation (EC) No 2037/2000 of the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer (15) , Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (16) or Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals (17) ).
Information regarding relevant Community safety, health and environmental provisions (for example, Seveso category/named substances in Annex I of Council Directive 96/82/EC (18) ) or national information on the regulatory status of the substance or mixture (including the substances in the mixture), including advice regarding action that should be taken by the recipient as a result of these provisions shall be provided. Where relevant the national laws of the relevant Member States which implement these provisions and any other national measures that may be relevant shall be mentioned.
If the substance or mixture covered by this safety data sheet is the subject of specific provisions in relation to protection of human health or the environment at Community level (such as authorisations given under Title VII or restrictions under Title VIII) these provisions shall be mentioned.
It shall be indicated if a chemical safety assessment has been carried out for the substance or the mixture by the supplier.
This section of the safety data sheet shall describe the information relevant to the compilation of the safety data sheet. It shall incorporate other information that is not included in Sections 1 to 15, including information on revision of the safety data sheet such as:
in case of a revised safety data sheet, a clear indication of where changes have been made to the previous version of the safety data sheet, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes, if appropriate. A supplier of a substance or mixture shall maintain an explanation of the changes and provide it upon request;
a key or legend to abbreviations and acronyms used in the safety data sheet;
key literature references and sources for data;
in the case of mixtures, an indication of which of the methods of evaluating information referred to in Article 9 of Regulation (EC) No 1272/2008 was used for the purpose of classification;
list of relevant R phrases, hazard statements, safety phrases and/or precautionary statements. Write out the full text of any statements which are not written out in full under Sections 2 to 15;
advice on any training appropriate for workers to ensure protection of human health and the environment.
If in accordance with Article 31(10) a supplier of a mixture chooses to identify and inform about the classification necessary from 1 June 2015 in advance of using it for classification and labelling on the package, he may include this classification in this section.
The safety data sheet shall include the following 16 headings in accordance with Article 31(6) and in addition the subheadings also listed except Section 3, where only subsection 3.1 or 3.2 need to be included as appropriate:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Criteria for substances registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):
[F1substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;]
substances:
with dispersive or diffuse use(s) particularly where such substances are used in consumer [F1mixtures] or incorporated into consumer articles; and
[F1for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008.]
Textual Amendments
Einecs No | Name/Group | CAS No |
---|---|---|
200-061-5 | D-glucitol C 6 H 14 O 6 | 50-70-4 |
200-066-2 | Ascorbic acid C 6 H 8 O 6 | 50-81-7 |
200-075-1 | Glucose C 6 H 12 O 6 | 50-99-7 |
200-233-3 | Fructose C 6 H 12 O 6 | 57-48-7 |
200-294-2 | L-lysine C 6 H 14 N 2 O 2 | 56-87-1 |
200-334-9 | Sucrose, pure C 12 H 22 O 11 | 57-50-1 |
200-405-4 | α-tocopheryl acetate C 31 H 52 O 3 | 58-95-7 |
200-416-4 | Galactose C 6 H 12 O 6 | 59-23-4 |
200-432-1 | DL-methionine C 5 H 11 NO 2 S | 59-51-8 |
200-559-2 | Lactose C 12 H 22 O 11 | 63-42-3 |
200-711-8 | D-mannitol C 6 H 14 O 6 | 69-65-8 |
201-771-8 | L-sorbose C 6 H 12 O 6 | 87-79-6 |
204-664-4 | Glycerol stearate, pure C 21 H 42 O 4 | 123-94-4 |
204-696-9 | Carbon dioxide CO 2 | 124-38-9 |
205-278-9 | Calcium pantothenate, D-form C 9 H 17 NO 5.1/2 Ca | 137-08-6 |
205-756-7 | DL-phenylalanine C 9 H 11 NO 2 | 150-30-1 |
208-407-7 | Sodium gluconate C 6 H 12 O 7 .Na | 527-07-1 |
215-665-4 | Sorbitan oleate C 24 H 44 O 6 | 1338-43-8 |
231-098-5 | Krypton Kr | 7439-90-9 |
231-110-9 | Neon Ne | 7440-01-9 |
231-147-0 | Argon Ar | 7440-37-1 |
231-168-5 | Helium He | 7440-59-7 |
231-172-7 | Xenon Xe | 7440-63-3 |
231-783-9 | Nitrogen N 2 | 7727-37-9 |
231-791-2 | Water, distilled, conductivity or of similar purity H 2 O | 7732-18-5 |
232-307-2 | Lecithins The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid | 8002-43-5 |
232-436-4 | Syrups, hydrolyzed starch A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins | 8029-43-4 |
232-442-7 | Tallow, hydrogenated | 8030-12-4 |
232-675-4 | Dextrin | 9004-53-9 |
232-679-6 | Starch High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by heating in the presence of water | 9005-25-8 |
232-940-4 | Maltodextrin | 9050-36-6 |
238-976-7 | Sodium D-gluconate C 6 H 12 O 7 .xNa | 14906-97-9 |
248-027-9 | D-glucitol monostearate C 24 H 48 O 7 | 26836-47-5 |
262-988-1 | Fatty acids, coco, Me esters | 61788-59-8 |
265-995-8 | Cellulose pulp | 65996-61-4 |
266-948-4 | Glycerides, C 16-18 and C 18 -unsaturated. This substance is identified by SDA Substance Name: C 16 -C 18 and C 18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00 | 67701-30-8 |
268-616-4 | Syrups, corn, dehydrated | 68131-37-3 |
269-658-6 | Glycerides, tallow mono-, di- and tri-, hydrogenated | 68308-54-3 |
270-312-1 | Glycerides, C 16-18 and C 18 -unsaturated, mono- and di- This substance is identified by SDA Substance Name: C 16 -C 18 and C 18 unsaturated alkyl and C 16 -C 18 and C 18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00 | 68424-61-3 |
288-123-8 | Glycerides, C 10-18 | 85665-33-4] |
a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or
a substance solely intended to provide a specific physicochemical characteristic functions as intended.
Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal.
Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C 6 to C 24 and their potassium, sodium, calcium and magnesium salts; glycerol.
Liquefied petroleum gas, natural gas condensate, process gases and components thereof, coke, cement clinker, magnesia.
Glass, ceramic frits.
Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46. For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registration the precise information requirements will differ, according to tonnage, use and exposure. The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.
The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance. Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs. The registrant should also collect all other available and relevant information on the substance regardless whether testing for a given endpoint is required or not at the specific tonnage level. This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests.
In addition, information on exposure, use and risk management measures in accordance with Article 10 and this Annex should be collected. Considering all this information together, the registrant will be able to determine the need to generate further information.
The registrant shall identify what information is required for the registration. First, the relevant Annex or Annexes to be followed shall be identified, according to tonnage. These Annexes set out the standard information requirements, but shall be considered in conjunction with Annex XI, which allows variation from the standard approach, where it can be justified. In particular, information on exposure, use and risk management measures shall be considered at this stage in order to determine the information needs for the substance.
The registrant shall then compare the information needs for the substance with the information already available and identify where there are gaps. It is important at this stage to ensure that the available data is relevant and has sufficient quality to fulfil the requirements.
In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted.
In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements.
Note 1 : If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions. U.K.
Note 2 : The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justification. U.K.
Articles 11 or 19 foresee that parts of the registration may be submitted by a lead registrant on behalf of other registrants.
In this case, the lead registrant shall identify the other registrants specifying:
their name, address, telephone number, fax number and e-mail address,
parts of the present registration which apply to other registrants.
Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.
Any other registrant shall identify the lead registrant submitting on his behalf specifying:
his name, address, telephone number, fax number and e-mail address,
parts of the registration which are submitted by the lead registrant.
Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.
For each substance, the information given in this section shall be sufficient to enable each substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.
the calendar year of the registration (estimated quantity)
Precise details of the process, particularly those of a commercially sensitive nature, are not required.
Where applicable, an indication of the uses which the registrant advises against and why (i.e. non-statutory recommendations by supplier). This need not be an exhaustive list.
In addition, for each entry, the reasons why no classification is given for a hazard class or differentiation of a hazard class should be provided (i.e. if data are lacking, inconclusive, or conclusive but not sufficient for classification),
This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required according to Article 31.
Where a Chemical Safety Report is not required, the following additional information is required:
industrial use; and/or
professional use; and/or
consumer use.
used in closed system; and/or
use resulting in inclusion into or onto matrix; and/or
non-dispersive use; and/or
dispersive use.
oral; and/or
dermal; and/or
inhalatory.
water; and/or
air; and/or
solid waste; and/or
soil.
accidental/infrequent; and/or
occasional; and/or
continuous/frequent.
Column 1 of this Annex establishes the standard information required for:
non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes;
phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III in accordance with Article 12(1)(a) and (b); and
substances manufactured or imported in quantities of 10 tonnes or more.
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of this Annex are required.
Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI with the exception of Section 3 on substance-tailored exposure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (20) .
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.
Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 10 tonnes or more in accordance with Article 12(1)(c). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annex VII. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the required standard information may be omitted, replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (22) .
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
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8.1. Skin irritation | |
8.1.1. In vivo skin irritation | 8.1.1. The study does not need to be conducted if:
|
8.2. Eye irritation | |
8.2.1. In vivo eye irritation | 8.2.1. The study does not need to be conducted if:
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8.4. Mutagenicity | |
8.4.2. In vitro cytogenicity study in mammalian cells or in vitro micronucleus study | 8.4.2. The study does not usually need to be conducted
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8.4.3. In vitro gene mutation study in mammalian cells, if a negative result in Annex VII, Section 8.4.1. and Annex VIII, Section 8.4.2. | 8.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available. |
8.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII. | |
8.5. Acute toxicity | 8.5. The study/ies do(es) not generally need to be conducted if:
In addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. |
8.5.2. By inhalation | 8.5.2. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. |
8.5.3. By dermal route | 8.5.3. Testing by the dermal route is appropriate if:(1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. |
8.6. Repeated dose toxicity | |
8.6.1. Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure. | 8.6.1. The short-term toxicity study (28 days) does not need to be conducted if:
The appropriate route shall be chosen on the following basis: Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The sub-chronic toxicity study (90 days) (Annex IX, Section 8.6.2) shall be proposed by the registrant if: the frequency and duration of human exposure indicates that a longer term study is appropriate; and one of the following conditions is met:
Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Article 40 or 41 in case of:
|
8.7. Reproductive toxicity | |
8.7.1. Screening for reproductive/developmental toxicity, one species (OECD 421 or 422), if there is no evidence from available information on structurally related substances, from (Q)SAR estimates or from in vitro methods that the substance may be a developmental toxicant | 8.7.1. This study does not need to be conducted if:
[F1If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.] In cases where there are serious concerns about the potential for adverse effects on fertility or development, either a pre-natal developmental toxicity study (Annex IX, Section 8.7.2) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) may be proposed by the registrant instead of the screening study. |
8.8. Toxicokinetics | |
8.8.1. Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information |
At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(d).
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 100 tonnes or more in accordance with Article 12(1)(d). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII and VIII. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (24) .
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
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8.4. If there is a positive result in any of the in vitro genotoxicity studies in Annex VII or VIII and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed by the registrant.If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered. | |
8.6. Repeated dose toxicity | |
8.6.1. Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex VIII requirements or if tests according to Section 8.6.2 of this Annex is proposed. In this case, Section 3 of Annex XI shall not apply. | |
8.6.2. Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure. | 8.6.2. The sub-chronic toxicity study (90 days) does not need to be conducted if:
The appropriate route shall be chosen on the following basis: Testing by the dermal route is appropriate if: (1) skin contact in production and/or use is likely; and (2) the physicochemical properties suggest a significant rate of absorption through the skin; and (3) one of the following conditions is met:
Testing by the inhalation route is appropriate if:
Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:
|
8.7. Reproductive toxicity | 8.7. The studies do not need to be conducted if:
[F1If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.] |
8.7.2. Pre-natal developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (B.31 of the Commission Regulation on test methods as specified in Article 13(3) or OECD 414). | 8.7.2. The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data. |
8.7.3. Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, if the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues. | 8.7.3. The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available date. |
Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.
At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(e).
Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in quantities of 1 000 tonnes or more in accordance with Article 12(1)(e). Accordingly, the information required in column 1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according to which the registrant may propose to omit the required standard information, replace it by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each adaptation under the appropriate headings in the registration dossier.
In addition to these specific rules, a registrant may propose to adapt the required standard information set out in column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (26) .
Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach) shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.
When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.
COLUMN 1 STANDARD INFORMATION REQUIRED | COLUMN 2 SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 |
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8.4. If there is a positive result in any of the in vitro genotoxicity studies in Annexes VII or VIII, a second in vivo somatic cell test may be necessary, depending on the quality and relevance of all the available data.If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered. | |
8.6.3. A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:
| |
8.6.4. Further studies shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 in case of:
| |
8.7. Reproductive toxicity | 8.7. The studies need not be conducted if:
[F1If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered. If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.] |
8.7.2. Developmental toxicity study, one species, most appropriate route of administration, having regard to the likely route of human exposure (OECD 414). | |
8.7.3. Two-generation reproductive toxicity study, one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure, unless already provided as part of Annex IX requirements | |
8.9.1. Carcinogenicity study | 8.9.1. A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:
[F1If the substance is classified as germ cell mutagen category 1A or 1B, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required.] |
Description of the analytical methods shall be provided on request, for the relevant compartments for which studies were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.
Annexes VII to X set out the information requirements for all substances manufactured or imported in quantities of:
one tonne or more in accordance with Article 12(1)(a),
10 tonnes or more in accordance with Article 12(1)(c),
100 tonnes or more in accordance with Article 12(1)(d), and
1 000 tonnes or more in accordance with Article 12(1)(e).
In addition to the specific rules set out in column 2 of Annexes VII to X, a registrant may adapt the standard testing regime in accordance with the general rules set out in Section 1 of this Annex. Under dossier evaluation the Agency may assess these adaptations to the standard testing regime.
Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:
adequacy for the purpose of classification and labelling and/or risk assessment;
sufficient documentation is provided to assess the adequacy of the study; and
the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.
Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:
adequacy for the purpose of classification and labelling and/or risk assessment;
adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3);
exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and
adequate and reliable documentation of the study is provided.
Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.
The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:
the proper selection and characterisation of the exposed and control groups;
adequate characterisation of exposure;
sufficient length of follow-up for disease occurrence;
valid method for observing an effect;
proper consideration of bias and confounding factors; and
a reasonable statistical reliability to justify the conclusion.
In all cases adequate and reliable documentation shall be provided.
There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion.
There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.
Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
further testing on vertebrate animals for that property shall be omitted,
further testing not involving vertebrate animals may be omitted.
In all cases adequate and reliable documentation shall be provided.
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:
results are derived from a (Q)SAR model whose scientific validity has been established,
the substance falls within the applicability domain of the (Q)SAR model,
results are adequate for the purpose of classification and labelling and/or risk assessment, and
adequate and reliable documentation of the applied method is provided.
The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.
Results obtained from suitable in vitro methods may indicate the presence of a certain dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ means sufficiently well developed according to internationally agreed test development criteria (e.g. the European Centre for the Validation of Alternative Methods (ECVAM)) criteria for the entry of a test into the prevalidation process). Depending on the potential risk, immediate confirmation requiring testing beyond the information foreseen in Annexes VII or VIII or proposed confirmation requiring testing beyond the information foreseen in Annexes IX or X for the respective tonnage level may be necessary.
If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the relevant test shall nevertheless be carried out at the appropriate tonnage level to confirm the negative result, unless testing is not required in accordance with Annexes VII to X or the other rules in this Annex.
Such confirmation may be waived, if the following conditions are met:
results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;
results are adequate for the purpose of classification and labelling and/or risk assessment; and
adequate and reliable documentation of the applied method is provided.
Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘ category ’ of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint. The Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the first registration deadline for phase-in substances.
The similarities may be based on:
a common functional group;
the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals; or
a constant pattern in the changing of the potency of the properties across the category.
If the group concept is applied, substances shall be classified and labelled on this basis.
In all cases results should:
be adequate for the purpose of classification and labelling and/or risk assessment,
have adequate and reliable coverage of the key parameters addressed in the corresponding test method referred to in Article 13(3),
cover an exposure duration comparable to or longer than the corresponding test method referred to in Article 13(3) if exposure duration is a relevant parameter, and
adequate and reliable documentation of the applied method shall be provided.
Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the substance required in certain studies may not be possible. The guidance given in the test methods referred to in Article 13(3), more specifically on the technical limitations of a specific method, shall always be respected.
the manufacturer or importer demonstrates and documents that all of the following conditions are fulfilled:
the results of the exposure assessment covering all relevant exposures throughout the life cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufacture and all identified uses as referred to in Annex VI section 3.5;
a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes (27) ;
the comparison of the derived DNEL or PNEC with the results of the exposure assessment shows that exposures are always well below the derived DNEL or PNEC;
where the substance is not incorporated in an article the manufacturer or importer demonstrates and documents for all relevant scenarios that throughout the life cycle strictly controlled conditions as set out in Article 18(4)(a) to (f) apply;
where the substance is incorporated in an article in which it is permanently embedded in a matrix or otherwise rigorously contained by technical means, it is demonstrated and documented that all of the following conditions are fulfilled:
the substance is not released during its life cycle;
the likelihood that workers or the general public or the environment are exposed to the substance under normal or reasonably foreseeable conditions of use is negligible; and
the substance is handled according to the conditions set out in Article 18(4)(a) to (f) during all manufacturing and production stages including the waste management of the substance during these stages.
Textual Amendments
The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks. The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identified uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a [F1mixture] or in an article.
In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out under other international and national programmes may also be taken into account.
The process which the downstream user goes through in carrying out the chemical safety assessment and in producing his Chemical Safety Report, involves three steps:
The downstream user shall develop exposure scenarios for uses not covered in a Safety Data Sheet supplied to him in accordance with Section 5 of Annex I.
If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report.
If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate, then he shall carry out the relevant assessments in accordance with Sections 1 to 4 of Annex I as appropriate to him.
In those cases where the downstream user considers that information in addition to that provided by the supplier is necessary for producing his Chemical Safety Report the downstream user shall gather this information. Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 38. He shall explain why he considers that additional information is necessary. While waiting for results of further testing, he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that he has put in place.
On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety Data Sheet if he is required to prepare one, as appropriate.
A risk characterisation shall be carried out for each new exposure scenario as prescribed in Section 6 of Annex I. The risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under the relevant heading(s).
When generating an exposure scenario it will be necessary to make initial assumptions about the operating conditions and risk managements measures. If the initial assumptions lead to a risk characterisation indicating inadequate protection of human health and the environment, then it shall be necessary to carry out an iterative process with amendment of one or a number of factors until adequate control can be demonstrated. This may require the generation of additional hazard or exposure information or appropriate alteration of the process, operating conditions or risk management measures. Therefore, iterations may be made between on the one hand developing and revising an (initial) exposure scenario, which includes developing and implementing risk management measures, and on the other hand generating further information to produce the definitive exposure scenario. The purpose of generating further information is to establish a more precise risk characterisation, based on a refined hazard assessment and/or exposure assessment.
The downstream user shall produce a Chemical Safety Report detailing his chemical safety assessment using Part B, Sections 9 and 10, of the format set out in Section 7 of Annex I and the other sections of this format, if appropriate.
Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures outlined in the exposure scenarios for the identified uses are communicated down the supply chain.
Textual Amendments
This Annex lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), and very persistent and very bioaccumulative substances (vPvB substances) as well as the information that must be considered for the purpose of assessing the P, B, and T properties of a substance.
For the identification of PBT substances and vPvB substances a weight-of-evidence determination using expert judgement shall be applied, by comparing all relevant and available information listed in Section 3.2 with the criteria set out in Section 1. This shall be applied in particular where the criteria set out in Section 1 cannot be applied directly to the available information.
A weight-of-evidence determination means that all available information bearing on the identification of a PBT or a vPvB substance is considered together, such as the results of monitoring and modelling, suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. The available results regardless of their individual conclusions shall be assembled together in a single weight-of-evidence determination.
The information used for the purposes of assessment of the PBT/vPvB properties shall be based on data obtained under relevant conditions.
The identification shall also take account of the PBT/vPvB-properties of relevant constituents of a substance and relevant transformation and/or degradation products.
This Annex shall apply to all organic substances, including organo-metals.
A substance that fulfils the persistence, bioaccumulation and toxicity criteria of Sections 1.1.1, 1.1.2 and 1.1.3 shall be considered to be a PBT substance.
A substance fulfils the persistence criterion (P) in any of the following situations:
the degradation half-life in marine water is higher than 60 days;
the degradation half-life in fresh or estuarine water is higher than 40 days;
the degradation half-life in marine sediment is higher than 180 days;
the degradation half-life in fresh or estuarine water sediment is higher than 120 days;
the degradation half-life in soil is higher than 120 days.
A substance fulfils the bioaccumulation criterion (B) when the bioconcentration factor in aquatic species is higher than 2 000 .
A substance fulfils the toxicity criterion (T) in any of the following situations:
the long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less than 0,01 mg/l;
the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC No 1272/2008;
there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.
A substance that fulfils the persistence and bioacumulation criteria of Sections 1.2.1 and 1.2.2 shall be considered to be a vPvB substance.
A substance fulfils the ‘ very persistent ’ criterion (vP) in any of the following situations:
the degradation half-life in marine, fresh or estuarine water is higher than 60 days;
the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;
the degradation half-life in soil is higher than 180 days.
A substance fulfils the ‘ very bioaccumulative ’ criterion (vB) when the bioconcentration factor in aquatic species is higher than 5 000 .
For the identification of PBT and vPvB substances in the registration dossier, the registrant shall consider the information as described in Annex I and in Section 3 of this Annex.
If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the registrant shall consider information relevant for screening for P, B, or T properties in accordance with Section 3.1 of this Annex. If the result from the screening tests or other information indicate that the substance may have PBT or vPvB properties, the registrant shall generate relevant additional information as set out in Section 3.2 of this Annex. In case the generation of relevant additional information would require information listed in Annexes IX or X, the registrant shall submit a testing proposal. Where the process and use conditions of the substance meet the conditions as specified in Section 3.2(b) or (c) of Annex XI the additional information may be omitted, and subsequently the substance is considered as if it is a PBT or vPvB in the registration dossier. No additional information needs to be generated for the assessment of PBT/vPvB properties if there is no indication of P or B properties following the result from the screening test or other information.
For dossiers for the purposes of identifying substances referred to in Article 57(d) and Article 57(e), relevant information from the registration dossiers and other available information as described in Section 3 shall be considered.
The following information shall be considered for screening for P, vP, B, vB and T properties in the cases referred to in the second paragraph of Section 2.1 and may be considered for screening for P, vP, B, vB and T properties in the context of Section 2.2.
Results from tests on ready biodegradation in accordance with Section 9.2.1.1 of Annex VII;
Results from other screening tests (e.g. enhanced ready test, tests on inherent biodegradability);
Results obtained from biodegradation (Q)SAR models in accordance with Section 1.3 of Annex XI;
Other information provided that its suitability and reliability can be reasonably demonstrated.
Octanol-water partitioning coefficient experimentally determined in accordance with Section 7.8 of Annex VII or estimated by (Q)SAR models in accordance with Section 1.3 of Annex XI;
Other information provided that its suitability and reliability can be reasonably demonstrated.
Short-term aquatic toxicity in accordance with Section 9.1 of Annex VII and Section 9.1.3 of Annex VIII;
Other information provided that its suitability and reliability can be reasonably demonstrated.
The following information shall be considered for the assessment of P, vP, B, vB and T properties, using a weight-of-evidence approach.
Results from simulation testing on degradation in surface water;
Results from simulation testing on degradation in soil;
Results from simulation testing on degradation in sediment;
Other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.
Results from a bioconcentration or bioaccumulation study in aquatic species;
Other information on the bioaccumulation potential provided that its suitability and reliability can be reasonably demonstrated, such as:
Results from a bioaccumulation study in terrestrial species;
Data from scientific analysis of human body fluids or tissues, such as blood, milk, or fat;
Detection of elevated levels in biota, in particular in endangered species or in vulnerable populations, compared to levels in their surrounding environment;
Results from a chronic toxicity study on animals;
Assessment of the toxicokinetic behaviour of the substance;
Information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.
Results from long-term toxicity testing on invertebrates as set out in Section 9.1.5 of Annex IX;
Results from long-term toxicity testing on fish as set out in Section 9.1.6 of Annex IX;
Results from growth inhibition study on aquatic plants as set out in in Section 9.1.2 of Annex VII;
The substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard phrases: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard phrase: H340), toxic for reproduction in Category 1A, 1B and/or 2 (assigned hazard phrases: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard phrase: H372 or H373), according to Regulation EC No 1272/2008;
Results from long-term or reproductive toxicity testing with birds as set out in Section 9.6.1 of Annex X;
Other information provided that its suitability and reliability can be reasonably demonstrated.]
a Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006. | ||||||
b Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.] ] | ||||||
[F8 [X2Entry Nr | Substance | Intrinsic property(ies) referred to in Article 57 | Transitional arrangements | Exempted (categories of) uses | Review periods | |
---|---|---|---|---|---|---|
Latest application date a | Sunset date b | |||||
1. | 5-tert-butyl-2,4,6-trinitro-m-xylene ( Musk xylene ) EC No : 201-329-4 CAS No : 81-15-2 | vPvB | 21 February 2013 | 21 August 2014 | — | — |
2. | 4,4’-Diaminodiphenylmethane (MDA) EC No : 202-974-4 CAS No : 101-77-9 | Carcinogenic (category 1B) | 21 February 2013 | 21 August 2014 | — | — |
3. | Hexabromocyclododecane ( HBCDD ) EC No : 221-695-9, 247-148-4, CAS No : 3194-55-6 25637-99-4 alpha-hexabromocyclododecane CAS No : 134237-50-6, beta-hexabromocyclododecane CAS No : 134237-51-7 gamma-hexabromocyclododecane CAS No : 134237-52-8 | PBT | 21 February 2014 | 21 August 2015 | — | — |
4. | Bis(2-ethylhexyl) phthalate ( DEHP ) EC No : 204-211-0 CAS No : 117-81-7 | Toxic for reproduction (category 1B) | 21 August 2013 | 21 February 2015 | Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC. | |
5. | Benzyl butyl phthalate ( BBP ) EC No : 201-622-7 CAS No : 85-68-7 | Toxic for reproduction (category 1B) | 21 August 2013 | 21 February 2015 | Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC. | |
6. | Dibutyl phthalate ( DBP ) EC No : 201-557-4 CAS No : 84-74-2 | Toxic for reproduction (category 1B) | 21 August 2013 | 21 February 2015 | Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC. | |
[F97. | Diisobutyl phthalate (DIBP) EC No: 201-553-2 CAS No: 84-69-5 | Toxic for reproduction (category 1B) | 21 August 2013 | 21 February 2015 | — | — |
8. | Diarsenic trioxide EC No: 215-481-4 CAS No: 1327-53-3 | Carcinogenic (category 1A) | 21 November 2013 | 21 May 2015 | — | — |
9. | Diarsenic pentaoxide EC No: 215-116-9 CAS No: 1303-28-2 | Carcinogenic (category 1A) | 21 November 2013 | 21 May 2015 | — | — |
10. | Lead chromate EC No: 231-846-0 CAS No: 7758-97-6 | Carcinogenic (category 1B) Toxic for reproduction (category 1A) | 21 November 2013 | 21 May 2015 | — | — |
11. | Lead sulfochromate yellow (C.I. Pigment Yellow 34) EC No: 215-693-7 CAS No: 1344-37-2 | Carcinogenic (category 1B) Toxic for reproduction (category 1A) | 21 November 2013 | 21 May 2015 | — | — |
12. | Lead chromate molybdate sulphate red (C.I. Pigment Red 104) EC No: 235-759-9 CAS No: 12656-85-8 | Carcinogenic (category 1B) Toxic for reproduction (category 1A) | 21 November 2013 | 21 May 2015 | ||
13. | Tris (2-chloroethyl) phosphate (TCEP) EC No: 204-118-5 CAS No: 115-96-8 | Toxic for reproduction (category 1B) | 21 February 2014 | 21 August 2015 | ||
14. | 2,4-Dinitrotoluene (2,4-DNT) EC No: 204-450-0 CAS No: 121-14-2 | Carcinogenic (category 1B) | 21 February 2014 | 21 August 2015 | ] | |
[F1015. | Trichloroethylene EC No: 201-167-4 CAS No: 79-01-6 | Carcinogenic (category 1B) | 21 October 2014 | 21 April 2016 | — | — |
16. | Chromium trioxide EC No: 215-607-8 CAS No: 1333-82-0 |
| 21 March 2016 | 21 September 2017 | — | — |
17. | Acids generated from chromium trioxide and their oligomers Group containing:
| Carcinogenic (category 1B) | 21 March 2016 | 21 September 2017 | — | — |
18. | Sodium dichromate EC No: 234-190-3 CAS No: 7789-12-0 10588-01-9 |
| 21 March 2016 | 21 September 2017 | — | — |
19. | Potassium dichromate EC No: 231-906-6 CAS No: 7778-50-9 |
| 21 March 2016 | 21 September 2017 | — | — |
20. | Ammonium dichromate EC No: 232-143-1 CAS No: 7789-09-5 |
| 21 March 2016 | 21 September 2017 | ||
21. | Potassium chromate EC No: 232-140-5 CAS No: 7789-00-6 |
| 21 March 2016 | 21 September 2017 | ||
22. | Sodium chromate EC No: 231-889-5 CAS No: 7775-11-3 |
| 21 March 2016 | 21 September 2017 | ] | |
[F1123. | Formaldehyde, oligomeric reaction products with aniline (technical MDA) EC No: 500-036-1 CAS No: 25214-70-4 | Carcinogenic (category 1B) | 22 February 2016 | 22 August 2017 | — | — |
24. | Arsenic acid EC No: 231-901-9 CAS No: 7778-39-4 | Carcinogenic (category 1A) | 22 February 2016 | 22 August 2017 | — | — |
25. | Bis(2-methoxyethyl) ether (diglyme) EC No: 203-924-4 CAS No: 111-96-6 | Toxic for reproduction (category 1B) | 22 February 2016 | 22 August 2017 | — | — |
26. | 1,2-dichloroethane (EDC) EC No: 203-458-1 CAS No: 107-06-2 | Carcinogenic (category 1B) | 22 May 2016 | 22 November 2017 | — | — |
27. | 2,2′-dichloro-4,4′-methylenedianiline (MOCA) EC No: 202-918-9 CAS No: 101-14-4 | Carcinogenic (category 1B) | 22 May 2016 | 22 November 2017 | — | — |
28. | Dichromium tris(chromate) EC No: 246-356-2 CAS No: 24613-89-6 | Carcinogenic (category 1B) | 22 July 2017 | 22 January 2019 | — | — |
29. | Strontium chromate EC No: 232-142-6 CAS No: 7789-06-2 | Carcinogenic (category 1B) | 22 July 2017 | 22 January 2019 | — | — |
30. | Potassium hydroxyoctaoxodizincatedichromate EC No: 234-329-8 CAS No: 11103-86-9 | Carcinogenic (category 1A) | 22 July 2017 | 22 January 2019 | — | — |
31. | Pentazinc chromate octahydroxide EC No: 256-418-0 CAS No: 49663-84-5 | Carcinogenic (category 1A) | 22 July 2017 | 22 January 2019 | — | —] |
Editorial Information
X2 Substituted by Corrigendum to Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Official Journal of the European Union L 44 of 18 February 2011).
Textual Amendments
F8 Inserted by Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Text with EEA relevance).
F9 Inserted by Commission Regulation (EU) No 125/2012 of 14 February 2012 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Text with EEA relevance).
This Annex lays down general principles for preparing dossiers to propose and justify:
[F12. . . . .]
[F1the identification of CMRs, PBTs, vPvBs, or a substance of equivalent concern in accordance with Article 59,]
restrictions of the manufacture, placing on the market or use of a substance within the Community.
Textual Amendments
F12Deleted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).
The relevant parts of Annex I shall be used for the methodology and format of any dossier according to this Annex.
For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance of equivalent concern according to Article 57(f).
A comparison of the available information with the criteria in Annex XIII for PBT according to Article 57(d), and vPvBs according to Article 57(e), or an assessment of the hazards and a comparison with Article 57(f), according to the relevant parts of Sections 1 to 4 of Annex I shall be completed. This shall be documented in the format set out in Part B of the Chemical Safety Report in Annex I.
The available use and exposure information and information on alternative substances and techniques shall be provided.
The proposal shall include the identity of the substance and the restriction(s) proposed for the manufacture, placing on the market or use(s) and a summary of the justification.
The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report.
Evidence shall be provided that implemented risk management measures (including those identified in registrations under Articles 10 to 14) are not sufficient.
Available information on alternative substances and techniques shall be provided, including:
information on the risks to human health and the environment related to the manufacture or use of the alternatives,
availability, including the time scale,
technical and economical feasibility.
Justification shall be provided that:
action is required on a Community-wide basis,
a restriction is the most appropriate Community wide measure which shall be assessed using the following criteria:
effectiveness: the restriction must be targeted to the effects or exposures that cause the risks identified, capable of reducing these risks to an acceptable level within a reasonable period of time and proportional to the risk;
practicality: the restriction must be implementable, enforceable and manageable;
monitorability: it must be possible to monitor the result of the implementation of the proposed restriction.
The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI. To this end, the net benefits to human health and the environment of the proposed restriction may be compared to its net costs to manufacturers, importers, downstream users, distributors, consumers and society as a whole.
Information on any consultation of stakeholders and how their views have been taken into account shall be included in the dossier.
This Annex outlines the information that may be addressed by those submitting a socio-economic analysis (SEA) with an application for authorisation, as specified in Article 62(5)(a), or in connection with a proposed restriction, as specified in Article 69(6)(b).
The Agency shall prepare guidance for the preparation of SEAs. SEAs, or contributions to them, shall be submitted in the format specified by the Agency in accordance with Article 111.
However, the level of detail and scope of the SEA, or contributions to them, shall be the responsibility of the applicant for authorisation, or, in the case of a proposed restriction, the interested party. The information provided can address the socio-economic impacts at any level.
An SEA may include the following elements:
impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact on industry (e.g. manufacturers and importers). The impact on all other actors in the supply chain, downstream users and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existing processes, reporting and monitoring systems, installation of new technology, etc.) taking into account general trends in the market and technology,
impacts of a granted or refused authorisation, or a proposed restriction, on consumers. For example, product prices, changes in composition or quality or performance of products, availability of products, consumer choice, as well as effects on human health and the environment to the extent that these affect consumers,
social implications of a granted or refused authorisation, or a proposed restriction. For example job security and employment,
availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned. In the case of an application for authorisation, the social and/or economic impacts of using any available alternatives,
wider implications on trade, competition and economic development (in particular for SMEs and in relation to third countries) of a granted or refused authorisation, or a proposed restriction. This may include consideration of local, regional, national or international aspects,
in the case of a proposed restriction, proposals for other regulatory or non-regulatory measures that could meet the aim of the proposed restriction (this shall take account of existing legislation). This should include an assessment of the effectiveness and the costs linked to alternative risk management measures,
in the case of a proposed restriction or refused authorisation, the benefits for human health and the environment as well as the social and economic benefits of the proposed restriction. For example, worker health, environmental performance and the distribution of these benefits, for example, geographically, population groups,
an SEA may also address any other issue that is considered to be relevant by the applicant(s) or interested party.
Textual Amendments
[F13For substances which have been incorporated in this Annex as a consequence of restrictions adopted in the framework of Directive 76/769/EEC (Entries 1 to 58), the restrictions shall not apply to storage, keeping, treatment, filling into containers, or transfer from one container to another of these substances for export, unless the manufacture of the substances is prohibited. | |
n | |
Column 1 Designation of the substance, of the group of substances or of the mixture | Column 2 Conditions of restriction |
---|---|
1. Polychlorinated terphenyls (PCTs) | Shall not be placed on the market, or used:
|
2. Chloroethene (vinyl chloride)CAS No 75-01-4 EC No 200-831-0 | Shall not be used as propellant in aerosols for any use. Aerosols dispensers containing the substance as propellant shall not be placed on the market. |
[F13. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:(a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1.] | 1. Shall not be used in:
2. Articles not complying with paragraph 1 shall not be placed on the market.3. Shall not be placed on the market if they contain a colouring agent, unless required for fiscal reasons, or perfume, or both, if they:
4. Decorative oil lamps for supply to the general public shall not be placed on the market unless they conform to the European Standard on Decorative oil lamps (EN 14059) adopted by the European Committee for Standardisation (CEN).5. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and mixtures, suppliers shall ensure, before the placing on the market, that the following requirements are met:(a) lamp oils, labelled with R65 or H304, intended for supply to the general public are visibly, legibly and indelibly marked as follows: ‘ Keep lamps filled with this liquid out of the reach of children ’ ; and, by 1 December 2010 , ‘ Just a sip of lamp oil — or even sucking the wick of lamps — may lead to life-threatening lung damage ’ ; (b) grill lighter fluids, labelled with R65 or H304, intended for supply to the general public are legibly and indelibly marked by 1 December 2010 as follows: ‘ Just a sip of grill lighter may lead to life threatening lung damage ’ ; (c) lamp oils and grill lighters, labelled with R65 or H304, intended for supply to the general public are packaged in black opaque containers not exceeding 1 litre by 1 December 2010 . 6. No later than 1 June 2014 , the Commission shall request the European Chemicals Agency to prepare a dossier, in accordance with Article 69 of the present Regulation with a view to ban, if appropriate, grill lighter fluids and fuel for decorative lamps, labelled R65 or H304, intended for supply to the general public.7. Natural or legal persons placing on the market for the first time lamp oils and grill lighter fluids, labelled with R65 or H304, shall by 1 December 2011 , and annually thereafter, provide data on alternatives to lamp oils and grill lighter fluids labelled R65 or H304 to the competent authority in the Member State concerned. Member States shall make those data available to the Commission. |
4. Tris (2,3 dibromopropyl) phosphateCAS No 126-72-7 | 1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.2. Articles not complying with paragraph 1 shall not be placed on the market. |
5. BenzeneCAS No 71-43-2 EC No 200-753-7 | 1. Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0,0005 %) of the weight of the toy or part of toy.2. Toys and parts of toys not complying with paragraph 1 shall not be placed on the market.3. Shall not be placed on the market, or used,
4. However, paragraph 3 shall not apply to:(a) motor fuels which are covered by Directive 98/70/EC; (b) substances and mixtures for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation. |
6. Asbestos fibres(a) Crocidolite CAS No 12001-28-4 (b) Amosite CAS No 12172-73-5 (c) Anthophyllite CAS No 77536-67-5 (d) Actinolite CAS No 77536-66-4 (e) Tremolite CAS No 77536-68-6 (f) Chrysotile CAS No 12001-29-5 CAS No 132207-32-0 | [F141. The manufacture, placing on the market and use of these fibres and of articles and mixtures containing these fibres added intentionally is prohibited.]However, Member States may exempt the placing on the market and use of diaphragms containing chrysotile (point (f)) for existing electrolysis installations until they reach the end of their service life, or until suitable asbestos-free substitutes become available, whichever is the sooner. By 1 June 2011 Member States making use of this exemption shall provide a report to the Commission on the availability of asbestos free substitutes for electrolysis installations and the efforts undertaken to develop such alternatives, on the protection of the health of workers in the installations, on the source and quantities of chrysotile, on the source and quantities of diaphragms containing chrysotile, and the envisaged date of the end of the exemption. The Commission shall make this information publicly available. Following receipt of those reports, the Commission shall request the Agency to prepare a dossier in accordance with Article 69 with a view to prohibit the placing on the market and use of diaphragms containing chrysotile. 2. The use of articles containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 shall continue to be permitted until they are disposed of or reach the end of their service life. However, Member States may, for reasons of protection of human health, restrict, prohibit or make subject to specific conditions, the use of such articles before they are disposed of or reach the end of their service life.Member States may allow placing on the market of articles in their entirety containing asbestos fibres referred to in paragraph 1 which were already installed and/or in service before 1 January 2005 , under specific conditions ensuring a high level of protection of human health. Member States shall communicate these national measures to the Commission by 1 June 2011 . The Commission shall make this information publicly available. 3. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, the placing on the market and use of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if suppliers ensure before the placing on the market that articles bear a label in accordance with Appendix 7 to this Annex. |
7. Tris(aziridinyl)phosphinoxideCAS No 545-55-1 EC No 208-892-5 | 1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.2. Articles not complying with paragraph 1 shall not be placed on the market. |
8. Polybromobiphenyls; Polybrominatedbiphenyls (PBB)CAS No 59536-65-1 | 1. Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.2. Articles not complying with paragraph 1 shall not be placed on the market. |
9.(a) Soap bark powder (Quillaja saponaria) and its derivatives containing saponines CAS No 68990-67-0 EC 273-620-4 (b) Powder of the roots of Helleborus viridis and Helleborus niger (c) Powder of the roots of Veratrum album and Veratrum nigrum (d) Benzidine and/or its derivatives CAS No 92-87-5 EC No 202-199-1 (e) o-Nitrobenzaldehyde CAS No 552-89-6 EC No 209-025-3 (f) Wood powder | 1. Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.2. Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.3. However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid. |
10.(a) Ammonium sulphide CAS No 12135-76-1 EC No 235-223-4 (b) Ammonium hydrogen sulphide CAS No 12124-99-1 EC No 235-184-3 (c) Ammonium polysulphide CAS No 9080-17-5 EC No 232-989-1 | 1. Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.2. Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.3. However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid. |
11. Volatile esters of bromoacetic acids:(a) Methyl bromoacetate CAS No 96-32-2 EC No 202-499-2 (b) Ethyl bromoacetate CAS No 105-36-2 EC No 203-290-9 (c) Propyl bromoacetate CAS No 35223-80-4 (d) Butyl bromoacetate CAS No 18991-98-5 EC No 242-729-9 | 1. Shall not be used, in jokes and hoaxes or in mixtures or articles intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.2. Jokes and hoaxes, or mixtures or articles intended to be used as such, not complying with paragraph 1 shall not be placed on the market.3. However, paragraphs 1 and 2 shall not apply to stink bombs containing not more than 1,5 ml of liquid. |
12. 2-NaphthylamineCAS No 91-59-8 EC No 202-080-4 and its salts 13. BenzidineCAS No 92-87-5 EC No 202-199-1 and its salts 14. 4-NitrobiphenylCAS No 92-93-3 Einecs EC No 202-204-7 15. 4-Aminobiphenyl xenylamineCAS No 92-67-1 Einecs EC No 202-177-1 and its salts | The following shall apply to entries 12 to 15: Shall not be placed on the market, or used, as substances or in mixtures in concentrations greater than 0,1 % by weight. |
16. Lead carbonates:(a) Neutral anhydrous carbonate (PbCO 3 ) CAS No 598-63-0 EC No 209-943-4 (b) Trilead-bis(carbonate)-dihydroxide 2Pb CO 3 -Pb(OH) 2 CAS No 1319-46-6 EC No 215-290-6 | Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint. [F14However, Member States may, in accordance with the provisions of International Labour Organization (ILO) Convention 13, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors, as well as the placing on the market for such use. Where a Member State makes use of this derogation, it shall inform the Commission thereof.] |
17. Lead sulphates:(a) PbSO 4 CAS No 7446-14-2 EC No 231-198-9 (b) Pb x SO 4 CAS No 15739-80-7 EC No 239-831-0 | Shall not be placed on the market, or used, as substances or in mixtures, where the substance or mixture is intended for use as paint. [F14However, Member States may, in accordance with the provisions of International Labour Organization (ILO) Convention 13, permit the use on their territory of the substance or mixture for the restoration and maintenance of works of art and historic buildings and their interiors, as well as the placing on the market for such use. Where a Member State makes use of this derogation, it shall inform the Commission thereof.] |
18. Mercury compounds | Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use: (a) to prevent the fouling by micro-organisms, plants or animals of:
(b) in the preservation of wood; (c) in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture; (d) in the treatment of industrial waters, irrespective of their use. |
18a. MercuryCAS No 7439-97-6 EC No 231-106-7 | 1. Shall not be placed on the market:(a) in fever thermometers; (b) in other measuring devices intended for sale to the general public (such as manometers, barometers, sphygmomanometers, thermometers other than fever thermometers). 2. The restriction in paragraph 1 shall not apply to measuring devices that were in use in the Community before 3 April 2009 . However Member States may restrict or prohibit the placing on the market of such measuring devices.3. The restriction in paragraph 1(b) shall not apply to:(a) measuring devices more than 50 years old on 3 October 2007 ; (b) barometers (except barometers within point (a)) until 3 October 2009 . F154.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .[X45. The following mercury-containing measuring devices intended for industrial and professional uses shall not be placed on the market after 10 April 2014 :(a) barometers; (b) hygrometers; (c) manometers; (d) sphygmomanometers; (e) strain gauges to be used with plethysmographs; (f) tensiometers; (g) thermometers and other non-electrical thermometric applications. The restriction shall also apply to measuring devices under points (a) to (g) which are placed on the market empty if intended to be filled with mercury. 6. The restriction in paragraph 5 shall not apply to:(a) sphygmomanometers to be used: (i) in epidemiological studies which are ongoing on 10 October 2012 ; (ii) as reference standards in clinical validation studies of mercury-free sphygmomanometers; (b) thermometers exclusively intended to perform tests according to standards that require the use of mercury thermometers until 10 October 2017 ; (c) mercury triple point cells which are used for the calibration of platinum resistance thermometers. 7. The following mercury-using measuring devices intended for professional and industrial uses shall not be placed on the market after 10 April 2014 :(a) mercury pycnometers; (b) mercury metering devices for determination of the softening point. 8. The restrictions in paragraphs 5 and 7 shall not apply to:(a) measuring devices more than 50 years old on 3 October 2007 ; (b) measuring devices which are to be displayed in public exhibitions for cultural and historical purposes.] |
19. Arsenic compounds | 1. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use to prevent the fouling by micro-organisms, plants or animals of:
2. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters, irrespective of their use.3. Shall not be used in the preservation of wood. Furthermore, wood so treated shall not be placed on the market.4. By way of derogation from paragraph 3:(a) Relating to the substances and mixtures for the preservation of wood: these may only be used in industrial installations using vacuum or pressure to impregnate wood if they are solutions of inorganic compounds of the copper, chromium, arsenic (CCA) type C and if they are authorised in accordance with Article 5(1) of Directive 98/8/EC. Wood so treated shall not be placed on the market before fixation of the preservative is completed. (b) Wood treated with CCA solution in accordance with point (a) may be placed on the market for professional and industrial use provided that the structural integrity of the wood is required for human or livestock safety and skin contact by the general public during its service life is unlikely:
(c) Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that all treated wood placed on the market is individually labelled ‘ For professional and industrial installation and use only, contains arsenic ’ . In addition, all wood placed on the market in packs shall also bear a label stating ‘ Wear gloves when handling this wood. Wear a dust mask and eye protection when cutting or otherwise crafting this wood. Waste from this wood shall be treated as hazardous by an authorised undertaking ’ . (d) Treated wood referred to under point (a) shall not be used:
5. Wood treated with arsenic compounds that was in use in the Community before 30 September 2007 , or that was placed on the market in accordance with paragraph 4 may remain in place and continue to be used until it reaches the end of its service life.6. Wood treated with CCA type C that was in use in the Community before 30 September 2007 , or that was placed on the market in accordance with paragraph 4:
7. Member States may allow wood treated with other types of CCA solutions that was in use in the Community before 30 September 2007 :
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20. Organostannic compounds | 1. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is acting as biocide in free association paint.2. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture acts as biocide to prevent the fouling by micro-organisms, plants or animals of:(a) all craft irrespective of their length intended for use in marine, coastal, estuarine and inland waterways and lakes; (b) cages, floats, nets and any other appliances or equipment used for fish or shellfish farming; (c) any totally or partly submerged appliance or equipment. 3. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for use in the treatment of industrial waters.[F164. Tri-substituted organostannic compounds:(a) Tri-substituted organostannic compounds such as tributyltin (TBT) compounds and triphenyltin (TPT) compounds shall not be used after 1 July 2010 in articles where the concentration in the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin. (b) Articles not complying with point (a) shall not be placed on the market after 1 July 2010 , except for articles that were already in use in the Community before that date. 5. Dibutyltin (DBT) compounds:(a) Dibutyltin (DBT) compounds shall not be used after 1 January 2012 in mixtures and articles for supply to the general public where the concentration in the mixture or the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin. (b) Articles and mixtures not complying with point (a) shall not be placed on the market after 1 January 2012 , except for articles that were already in use in the Community before that date. (c) By way of derogation, points (a) and (b) shall not apply until 1 January 2015 to the following articles and mixtures for supply to the general public:
(d) By way of derogation, points (a) and (b) shall not apply to materials and articles regulated under Regulation (EC) No 1935/2004. 6. Dioctyltin (DOT) compound:(a) Dioctyltin (DOT) compounds shall not be used after 1 January 2012 in the following articles for supply to, or use by, the general public, where the concentration in the article, or part thereof, is greater than the equivalent of 0,1 % by weight of tin:
(b) Articles not complying with point (a) shall not be placed on the market after 1 January 2012 , except for articles that were already in use in the Community before that date.] |
21. Di-μ-oxo-di-n-butylstanniohydroxyborane/Dibutyltin hydrogen borate C 8 H 19 BO 3 Sn (DBB)CAS No 75113-37-0 EC No 401-040-5 | Shall not be placed on the market, or used, as a substance, or in mixtures in a concentration equal to, or greater than 0,1 % by weight. However, the first paragraph shall not apply to this substance (DBB) or mixtures containing it if these are intended solely for conversion into articles, among which this substance will no longer feature in a concentration equal to or greater than 0,1 %. |
22. PentachlorophenolCAS No 87-86-5 EC No 201-778-6 and its salts and esters | Shall not be placed on the market, or used,
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23. CadmiumCAS No 7440-43-9 EC No 231-152-8 and its compounds | For the purpose of this entry, the codes and chapters indicated in square brackets are the codes and chapters of the tariff and statistical nomenclature of Common Customs Tariff as established by Council Regulation (EEC) No 2658/87 a . [F17 [F181. Shall not be used in mixtures and articles produced from the following synthetic organic polymers (hereafter referred to as plastic material):
Mixtures and articles produced from plastic material as listed above shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight of the plastic material.] [F19By way of derogation, the second subparagraph shall not apply to articles placed on the market before 10 December 2011 .] The first and second subparagraphs apply without prejudice to Council Directive 94/62/EC m and acts adopted on its basis. [F20By 19 November 2012 , in accordance with Article 69, the Commission shall ask the European Chemicals Agency to prepare a dossier conforming to the requirements of Annex XV in order to assess whether the use of cadmium and its compounds in plastic material, other than that listed in subparagraph 1, should be restricted.] 2. Shall not be used in paints [3208] [3209].For paints with a zinc content exceeding 10 % by weight of the paint, the concentration of cadmium (expressed as Cd metal) shall not be equal to or greater than 0,1 % by weight. Painted articles shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,1 % by weight of the paint on the painted article. 3. By way of derogation, paragraphs 1 and 2 shall not apply to articles coloured with mixtures containing cadmium for safety reasons.4. By way of derogation, paragraph 1, second subparagraph shall not apply to:
Suppliers shall ensure, before the placing on the market of mixtures and articles containing recovered PVC for the first time, that these are visibly, legibly and indelibly marked as follows: ‘ Contains recovered PVC ’ or with the following pictogram: In accordance with Article 69 of this Regulation, the derogation granted in paragraph 4 will be reviewed, in particular with a view to reducing the limit value for cadmium and to reassess the derogation for the applications listed in points (a) to (e), by 31 December 2017 .] 5. For the purpose of this entry, ‘ cadmium plating ’ means any deposit or coating of metallic cadmium on a metallic surface.Shall not be used for cadmium plating metallic articles or components of the articles used in the following sectors/applications: (a) equipment and machinery for:
(b) equipment and machinery for the production of:
In any case, whatever their use or intended final purpose, the placing on the market of cadmium-plated articles or components of such articles used in the sectors/applications listed in points (a) and (b) above and of articles manufactured in the sectors listed in point (b) above is prohibited. 6. The provisions referred to in paragraph 5 shall also be applicable to cadmium-plated articles or components of such articles when used in the sectors/applications listed in points (a) and (b) below and to articles manufactured in the sectors listed in (b) below:(a) equipment and machinery for the production of:
(b) equipment and machinery for the production of:
7. However, the restrictions in paragraphs 5 and 6 shall not apply to:
[F218. Shall not be used in brazing fillers in concentration equal to or greater than 0,01 % by weight.Brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight. For the purpose of this paragraph brazing shall mean a joining technique using alloys and undertaken at temperatures above 450 °C. 9. By way of derogation, paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications and to brazing fillers used for safety reasons.10. Shall not be used or placed on the market if the concentration is equal to or greater than 0,01 % by weight of the metal in:(i) metal beads and other metal components for jewellery making; (ii) metal parts of jewellery and imitation jewellery articles and hair accessories, including:
[F1911. By way of derogation, paragraph 10 shall not apply to articles placed on the market before 10 December 2011 and jewellery more than 50 years old on 10 December 2011 .] ] |
24. Monomethyl — tetrachlorodiphenyl methaneTrade name: Ugilec 141 CAS No 76253-60-6 | 1. Shall not be placed on the market, or used, as a substance or in mixtures.Articles containing the substance shall not be placed on the market. 2. By way of derogation, paragraph 1 shall not apply:(a) in the case of plant and machinery already in service on 18 June 1994 , until such plant and machinery is disposed of; (b) in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994 . For the purposes of point (a) Member States may, on grounds of human health protection and environmental protection, prohibit within their territory the use of such plant or machinery before it is disposed of. |
25. Monomethyl-dichloro-diphenyl methaneTrade name: Ugilec 121 Ugilec 21 | Shall not be placed on the market, or used, as a substance or in mixtures. Articles containing the substance shall not be placed on the market. |
26. Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomersTrade name: DBBT CAS No 99688-47-8 | Shall not be placed on the market, or used, as a substance or in mixtures. Articles containing the substance shall not be placed on the market. |
27. NickelCAS No 7440-02-0 EC No 231-111-4 and its compounds | 1. Shall not be used:(a) in any post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate of nickel release from such post assemblies is less than 0,2 μg/cm 2 /week (migration limit); (b) in articles intended to come into direct and prolonged contact with the skin such as:
if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0,5 μg/cm 2 /week. (c) in articles referred to in point (b) where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such articles coming into direct and prolonged contact with the skin will not exceed 0,5 μg/cm 2 /week for a period of at least two years of normal use of the article. 2. Articles which are the subject of paragraph 1 shall not be placed on the market unless they conform to the requirements set out in that paragraph.3. The standards adopted by the European Committee for Standardisation (CEN) shall be used as the test methods for demonstrating the conformity of articles to paragraphs 1 and 2. |
28. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2 (Table 3.2) and listed as follows:
29. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as germ cell mutagen category 1A or 1B (Table 3.1) or mutagen category 1 or 2 (Table 3.2) and listed as follows:
30. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to reproduction category 1 or 2 (Table 3.2) and listed as follows:
| Without prejudice to the other parts of this Annex the following shall apply to entries 28 to 30: 1. Shall not be placed on the market, or used,
for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:
Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows: ‘Restricted to professional users’ . 2. By way of derogation, paragraph 1 shall not apply to: (a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC; (b) cosmetic products as defined by Directive 76/768/EEC; (c) the following fuels and oil products:
(d) artists’ paints covered by Directive 1999/45/EC [F22;] (e) [X5the substances listed in Appendix 11, column 1, for the applications or uses listed in Appendix 11, column 2. Where a date is specified in column 2 of Appendix 11, the derogation shall apply until the said date.] |
31.(a) Creosote; wash oil CAS No 8001-58-9 EC No 232-287-5 (b) Creosote oil; wash oil CAS No 61789-28-4 EC No 263-047-8 (c) Distillates (coal tar), naphthalene oils; naphthalene oil CAS No 84650-04-4 EC No 283-484-8 (d) Creosote oil, acenaphthene fraction; wash oil CAS No 90640-84-9 EC No 283-484-8EC No 292-605-3 (e) Distillates (coal tar), upper; heavy anthracene oil CAS No 65996-91-0 EC No 266-026-1 (f) Anthracene oil CAS No 90640-80-5 EC No 292-602-7 (g) Tar acids, coal, crude; crude phenols CAS No 65996-85-2 EC No 266-019-3 (h) Creosote, wood CAS No 8021-39-4 EC No 232-419-1 (i) Low temperature tar oil, alkaline; extract residues (coal), low temperature coal tar alkaline CAS No 122384-78-5 EC No 310-191-5 | 1. Shall not be placed on the market, or used, as substances or in mixtures where the substance or mixture is intended for the treatment of wood. Furthermore, wood so treated shall not be placed on the market.2. By way of derogation from paragraph 1:(a) The substances and mixtures may be used for wood treatment in industrial installations or by professionals covered by Community legislation on the protection of workers for in situ retreatment only if they contain: (i) benzo[a]pyrene at a concentration of less than 50 mg/kg (0,005 % by weight), and (ii) water extractable phenols at a concentration of less than 3 % by weight. Such substances and mixtures for use in wood treatment in industrial installations or by professionals:
Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is visibly, legibly and indelibly marked as follows: ‘For use in industrial installations or professional treatment only’ . (b) Wood treated in industrial installations or by professionals according to subparagraph (a) which is placed on the market for the first time or retreated in situ may be used for professional and industrial use only, for example on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (for example stakes for tree support) and in harbours and waterways. (c) The prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31 (a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use. 3. Treated wood referred to under paragraph 2(b) and (c) shall not be used:
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32. ChloroformCAS No 67-66-3 EC No 200-663-8 34. 1,1,2-TrichloroethaneCAS No 79-00-5 EC No 201-166-9 35. 1,1,2,2-TetrachloroethaneCAS No 79-34-5 EC No 201-197-8 36. 1,1,1,2-TetrachloroethaneCAS No 630-20-6 37. PentachloroethaneCAS No 76-01-7 EC No 200-925-1 38. 1,1-DichloroetheneCAS No 75-35-4 EC No 200-864-0 | Without prejudice to the other parts of this Annex, the following shall apply to entries 32 to 38. 1. Shall not be placed on the market, or used,
where the substance or mixture is intended for supply to the general public and/or is intended for diffusive applications such as in surface cleaning and cleaning of fabrics. 2. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures containing them in concentrations equal to or greater than 0,1 % by weight is visibly, legibly and indelibly marked as follows:‘For use in industrial installations only’ . By way of derogation this provision shall not apply to: (a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC; (b) cosmetic products as defined by Directive 76/768/EEC. |
[F140. Substances classified as flammable gases category 1 or 2, flammable liquids categories 1, 2 or 3, flammable solids category 1 or 2, substances and mixtures which, in contact with water, emit flammable gases, category 1, 2 or 3, pyrophoric liquids category 1 or pyrophoric solids category 1, regardless of whether they appear in Part 3 of Annex VI [F14to Regulation (EC) No 1272/2008] or not.] | 1. Shall not be used, as substance or as mixtures in aerosol dispensers where these aerosol dispensers are intended for supply to the general public for entertainment and decorative purposes such as the following:
2. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances, suppliers shall ensure before the placing on the market that the packaging of aerosol dispensers referred to above is marked visibly, legibly and indelibly with:‘For professional users only’ . 3. By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol dispensers referred to Article 8 (1a) of Council Directive 75/324/EEC b .4. The aerosol dispensers referred to in paragraphs 1 and 2 shall not be placed on the market unless they conform to the requirements indicated. |
41. HexachloroethaneCAS No 67-72-1 EC No 200-666-4 | Shall not be placed on the market, or used, as substance or in mixtures, where the substance or mixture is intended for the manufacturing or processing of non-ferrous metals. |
[ F23 ] | |
43. Azocolourants and Azodyes | 1. Azodyes which, by reductive cleavage of one or more azo groups, may release one or more of the aromatic amines listed in Appendix 8, in detectable concentrations, i.e. above 30 mg/kg (0,003 % by weight) in the articles or in the dyed parts thereof, according to the testing methods listed in Appendix 10, shall not be used, in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity, such as:
2. Furthermore, the textile and leather articles referred to in paragraph 1 shall not be placed on the market unless they conform to the requirements set out in that paragraph.3. Azodyes, which are contained in Appendix 9, ‘ List of azodyes ’ shall not be placed on the market, or used, as substances, or in mixtures in concentrations greater than 0,1 % by weight, where the substance or the mixture is intended for colouring textile and leather articles. |
[ F24 ] | |
45. Diphenylether, octabromo derivativeC 12 H 2 Br 8 O | 1. Shall not be placed on the market, or used:
2. Articles shall not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concentrations greater than 0,1 % by weight.3. By way of derogation, paragraph 2 shall not apply:
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46.(a) Nonylphenol C 6 H4(OH)C 9 H 19 CAS 25154-52-3 EC 246-672-0 (b) Nonylphenol ethoxylates (C 2 H 4 O) n C 15 H 24 O | Shall not be placed on the market, or used, as substances or in mixtures in concentrations equal to or greater than 0,1 % by weight for the following purposes: (1) industrial and institutional cleaning except:
(2) domestic cleaning; (3) textiles and leather processing except:
(4) emulsifier in agricultural teat dips; (5) metal working except: uses in controlled closed systems where the washing liquid is recycled or incinerated; (6) manufacturing of pulp and paper; (7) cosmetic products; (8) other personal care products except: spermicides; (9) co-formulants in pesticides and biocides. However national authorisations for pesticides or biocidal products containing nonylphenol ethoxylates as co-formulant, granted before 17 July 2003 , shall not be affected by this restriction until their date of expiry. |
47. Chromium VI compounds | 1. Cement and cement-containing mixtures shall not be placed on the market, or used, if they contain, when hydrated, more than 2 mg/kg (0,0002 %) soluble chromium VI of the total dry weight of the cement.2. If reducing agents are used, then without prejudice to the application of other Community provisions on the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of cement or cement-containing mixtures is visibly, legibly and indelibly marked with information on the packing date, as well as on the storage conditions and the storage period appropriate to maintaining the activity of the reducing agent and to keeping the content of soluble chromium VI below the limit indicated in paragraph 1.3. By way of derogation, paragraphs 1 and 2 shall not apply to the placing on the market for, and use in, controlled closed and totally automated processes in which cement and cement-containing mixtures are handled solely by machines and in which there is no possibility of contact with the skin.[F254. The standard adopted by the European Committee for Standardization (CEN) for testing the water-soluble chromium (VI) content of cement and cement-containing mixtures shall be used as the test method for demonstrating conformity with paragraph 1.] |
48. TolueneCAS No 108-88-3 EC No 203-625-9 | Shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0,1 % by weight where the substance or mixture is used in adhesives or spray paints intended for supply to the general public. |
49. TrichlorobenzeneCAS No 120-82-1 EC No 204-428-0 | Shall not be placed on the market, or used, as a substance or in mixtures in a concentration equal to or greater than 0,1 % by weight for any use except:
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50. Polycyclic-aromatic hydrocarbons (PAH)(a) Benzo[a]pyrene (BaP) CAS No 50-32-8 (b) Benzo[e]pyrene (BeP) CAS No 192-97-2 (c) Benzo[a]anthracene (BaA) CAS No 56-55-3 (d) Chrysen (CHR) CAS No 218-01-9 (e) Benzo[b]fluoranthene (BbFA) CAS No 205-99-2 (f) Benzo[j]fluoranthene (BjFA) CAS No 205-82-3 (g) Benzo[k]fluoranthene (BkFA) CAS No 207-08-9 (h) Dibenzo[a,h]anthracene (DBAhA) CAS No 53-70-3 | 1. From 1 January 2010 , extender oils shall not be placed on the market, or used for the production of tyres or parts of tyres if they contain:
These limits shall be regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by weight as measured by the Institute of Petroleum standard IP346: 1998 (Determination of PCA in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method), provided that compliance with the limit values of BaP and of the listed PAHs, as well as the correlation of the measured values with the PCA extract, is controlled by the manufacturer or importer every six months or after each major operational change, whichever is earlier. 2. Furthermore, tyres and treads for retreading manufactured after 1 January 2010 shall not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1.These limits shall be regarded as kept, if the vulcanised rubber compounds do not exceed the limit of 0,35 % Bay protons as measured and calculated by ISO 21461 (Rubber vulcanised — Determination of aromaticity of oil in vulcanised rubber compounds). 3. By way of derogation, paragraph 2 shall not apply to retreaded tyres if their tread does not contain extender oils exceeding the limits referred to in paragraph 1.4. For the purpose of this entry ‘ tyres ’ shall mean tyres for vehicles covered by:
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51. The following phthalates (or other CAS and EC numbers covering the substance):(a) Bis (2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7 EC No 204-211-0 (b) Dibutyl phthalate (DBP) CAS No 84-74-2 EC No 201-557-4 (c) Benzyl butyl phthalate (BBP) CAS No 85-68-7 EC No 201-622-7 | 1. Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles.2. Toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market.3. The Commission shall re-evaluate, by 16 January 2010 , the measures provided for in relation to this entry in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly.4. For the purpose of this entry ‘ childcare article ’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. |
52. The following phthalates (or other CAS- and EC numbers covering the substance):(a) Di- ‘ isononyl ’ phthalate (DINP) CAS No 28553-12-0 and 68515-48-0 EC No 249-079-5 and 271-090-9 (b) Di- ‘ isodecyl ’ phthalate (DIDP) CAS No 26761-40-0 and 68515-49-1 EC No 247-977-1 and 271-091-4 (c) Di-n-octyl phthalate (DNOP) CAS No 117-84-0 EC No 204-214-7 | 1. Shall not be used as substances or in mixtures, in concentrations greater than 0,1 % by weight of the plasticised material, in toys and childcare articles which can be placed in the mouth by children.2. Such toys and childcare articles containing these phthalates in a concentration greater than 0,1 % by weight of the plasticised material shall not be placed on the market.3. The Commission shall re-evaluate, by 16 January 2010 , the measures provided for in relation to this entry in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly.4. For the purpose of this entry ‘ childcare article ’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. |
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54. 2-(2-methoxyethoxy)ethanol (DEGME)CAS No 111-77-3 EC No 203-906-6 | Shall not be placed on the market after 27 June 2010 , for supply to the general public, as a constituent of paints, paint strippers, cleaning agents, self-shining emulsions or floor sealants in concentrations equal to or greater than 0,1 % by weight. |
55. 2-(2-butoxyethoxy)ethanol (DEGBE)CAS No 112-34-5 EC No 203-961-6 | 1. Shall not be placed on the market for the first time after 27 June 2010 , for supply to the general public, as a constituent of spray paints or spray cleaners in aerosol dispensers in concentrations equal to or greater than 3 % by weight.2. Spray paints and spray cleaners in aerosol dispensers containing DEGBE and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010 .3. Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that paints other than spray paints containing DEGBE in concentrations equal to or greater than 3 % by weight of that are placed on the market for supply to the general public are visibly, legibly and indelibly marked by 27 December 2010 as follows:‘Do not use in paint spraying equipment’ . |
[F1456. Methylenediphenyl diisocyanate (MDI)CAS No 26447-40-5 EC No 247-714-0 including the following specific isomers: (a) 4,4’-Methylenediphenyl diisocyanate: CAS No 101-68-8 EC No 202-966-0; (b) 2,4’-Methylenediphenyl diisocyanate: CAS No 5873-54-1 EC No 227-534-9; (c) 2,2’-Methylenediphenyl diisocyanate: CAS No 2536-05-2 EC No 219-799-4] | 1. Shall not be placed on the market after 27 December 2010 , as a constituent of mixtures in concentrations equal to or greater than 0,1 % by weight of MDI for supply to the general public, unless suppliers shall ensure before the placing on the market that the packaging:(a) contains protective gloves which comply with the requirements of Council Directive 89/686/EEC i ; (b) is marked visibly, legibly and indelibly as follows, and without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures:
2. By way of derogation, paragraph 1(a) shall not apply to hot melt adhesives. |
57. CyclohexaneCAS No 110-82-7 EC No 203-806-2 | 1. Shall not be placed on the market for the first time after 27 June 2010 , for supply to the general public, as a constituent of neoprene-based contact adhesives in concentrations equal to or greater than 0,1 % by weight in package sizes greater than 350 g.2. Neoprene-based contact adhesives containing cyclohexane and not conforming to paragraph 1 shall not be placed on the market for supply to the general public after 27 December 2010 .3. Without prejudice to other Community legislation concerning the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that neoprene-based contact adhesives containing cyclohexane in concentrations equal to or greater than 0,1 % by weight that are placed on the market for supply to the general public after 27 December 2010 are visibly, legibly and indelibly marked as follows:
|
58. Ammonium nitrate (AN)CAS No 6484-52-2 EC No 229-347-8 | 1. Shall not be placed on the market for the first time after 27 June 2010 as a substance, or in mixtures that contain more than 28 % by weight of nitrogen in relation to ammonium nitrate, for use as a solid fertiliser, straight or compound, unless the fertiliser complies with the technical provisions for ammonium nitrate fertilisers of high nitrogen content set out in Annex III to Regulation (EC) No 2003/2003 of the European Parliament and of the Council j .2. Shall not be placed on the market after 27 June 2010 as a substance, or in mixtures that contain 16 % or more by weight of nitrogen in relation to ammonium nitrate except for supply to:(a) downstream users and distributors, including natural or legal persons licensed or authorised in accordance with Council Directive 93/15/EEC l ; (b) farmers for use in agricultural activities, either full time or part time and not necessarily related to the size of the land area. For the purposes of this subparagraph: (i) ‘ farmer ’ shall mean a natural or legal person, or a group of natural or legal persons, whatever legal status is granted to the group and its members by national law, whose holding is situated within Community territory, as referred to in Article 299 of the Treaty, and who exercises an agricultural activity; (ii) ‘ agricultural activity ’ shall mean the production, rearing or growing of agricultural products including harvesting, milking, breeding animals and keeping animals for farming purposes, or maintaining the land in good agricultural and environmental condition as established under Article 5 of Council Regulation (EC) No 1782/2003 k ; (c) natural or legal persons engaged in professional activities such as horticulture, plant growing in greenhouses, maintenance of parks, gardens or sport pitches, forestry or other similar activities. 3. However, for the restrictions in paragraph 2, Member States may until 1 July 2014 , for socioeconomic reasons, apply a limit of up to 20 % by weight of nitrogen in relation to ammonium nitrate for substances and mixtures placed on the market within their territories. They shall inform the Commission and other Member States thereof. |
[F1659. DichloromethaneCAS No 75-09-2 EC No: 200-838-9 | 1. Paint strippers containing dichloromethane in a concentration equal to or greater than 0,1 % by weight shall not be:(a) placed on the market for the first time for supply to the general public or to professionals after 6 December 2010 ; (b) placed on the market for supply to the general public or to professionals after 6 December 2011 ; (c) used by professionals after 6 June 2012 . For the purposes of this entry: (i) ‘ professional ’ means any natural or legal person, including workers and self-employed workers undertaking paint stripping in the course of their professional activity outside an industrial installation; (ii) ‘ industrial installation ’ means a facility used for paint stripping activities. 2. By way of derogation from paragraph 1, Member States may allow on their territories and for certain activities the use, by specifically trained professionals, of paint strippers containing dichloromethane and may allow the placing on the market of such paint strippers for supply to those professionals.Member States making use of this derogation shall define appropriate provisions for the protection of the health and safety of those professionals using paint strippers containing dichloromethane and shall inform the Commission thereof. Those provisions shall include a requirement that a professional shall hold a certificate that is accepted by the Member State in which that professional operates, or provide other documentary evidence to that effect, or be otherwise approved by that Member State, so as to demonstrate proper training and competence to safely use paint strippers containing dichloromethane. The Commission shall prepare a list of the Member States which have made use of the derogation in this paragraph and make it publicly available over the Internet. 3. A professional benefiting from the derogation referred to in paragraph 2 shall operate only in Member States which have made use of that derogation. The training referred to in paragraph 2 shall cover as a minimum:(a) awareness, evaluation and management of risks to health, including information on existing substitutes or processes, which under their conditions of use are less hazardous to the health and safety of workers; (b) use of adequate ventilation; (c) use of appropriate personal protective equipment that complies with Directive 89/686/EEC. Employers and self-employed workers shall preferably replace dichloromethane with a chemical agent or process which, under its conditions of use, presents no risk, or a lower risk, to the health and safety of workers. Professional shall apply all relevant safety measures in practice, including the use of personal protective equipment. 4. Without prejudice to other Community legislation on workers protection, paint strippers containing dichloromethane in concentrations equal to or greater than 0,1 % by weight may be used in industrial installations only if the following minimum conditions are met:(a) effective ventilation in all processing areas, in particular for the wet processing and the drying of stripped articles: local exhaust ventilation at strip tanks supplemented by forced ventilation in those areas, so as to minimise exposure and to ensure compliance, where technically feasible, with relevant occupational exposure limits; (b) measures to minimise evaporation from strip tanks comprising: lids for covering strip tanks except during loading and unloading; suitable loading and unloading arrangements for strip tanks; and wash tanks with water or brine to remove excess solvent after unloading; (c) measures for the safe handling of dichloromethane in strip tanks comprising: pumps and pipework for transferring paint stripper to and from strip tanks; and suitable arrangements for safe cleaning of tanks and removal of sludge; (d) personal protective equipment that complies with Directive 89/686/EEC comprising: suitable protective gloves, safety goggles and protective clothing; and appropriate respiratory protective equipment where compliance with relevant occupational exposure limits cannot be otherwise achieved; (e) adequate information, instruction and training for operators in the use of such equipment. 5. Without prejudice to other Community provisions concerning the classification, labelling and packaging of substances and mixtures, by 6 December 2011 paint strippers containing dichloromethane in a concentration equal to or greater than 0,1 % by weight shall be visibly, legibly and indelibly marked as follows:‘ Restricted to industrial use and to professionals approved in certain EU Member States — verify where use is allowed. ’] |
[F2660. AcrylamideCAS No 79-06-1 | Shall not be placed on the market or used as a substance or constituent of mixtures in a concentration, equal to or greater than 0,1 % by weight for grouting applications after 5 November 2012 .] |
[X661. Dimethylfumarate (DMF)
| Shall not be used in articles or any parts thereof in concentrations greater than 0,1 mg/kg. Articles or any parts thereof containing DMF in concentrations greater than 0,1 mg/kg shall not be placed on the market.] |
[X363. Lead
and its compounds | 1. Shall not be placed on the market or used in any individual part of jewellery articles if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0,05 % by weight.2. For the purposes of paragraph 1:(i) ‘ jewellery articles ’ shall include jewellery and imitation jewellery articles and hair accessories, including: (a) bracelets, necklaces and rings; (b) piercing jewellery; (c) wrist watches and wrist-wear; (d) brooches and cufflinks; (ii) ‘ any individual part ’ shall include the materials from which the jewellery is made, as well as the individual components of the jewellery articles. 3. Paragraph 1 shall also apply to individual parts when placed on the market or used for jewellery-making.4. By way of derogation, paragraph 1 shall not apply to:(a) crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Council Directive 69/493/EEC n ; (b) internal components of watch timepieces inaccessible to consumers; (c) non-synthetic or reconstructed precious and semiprecious stones (CN code 7103 , as established by Regulation (EEC) No 2658/87), unless they have been treated with lead or its compounds or mixtures containing these substances; (d) enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of minerals melted at a temperature of at least 500 °C. 5. By way of derogation, paragraph 1 shall not apply to jewellery articles placed on the market for the first time before 9 October 2013 and jewellery articles produced before 10 December 1961 .6. By 9 October 2017 , the Commission shall re-evaluate this entry in the light of new scientific information, including the availability of alternatives and the migration of lead from the articles referred to in paragraph 1 and, if appropriate, modify this entry accordingly.] |
Editorial Information
X3 Substituted by Corrigendum to Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Official Journal of the European Union L 44 of 18 February 2011).
X4 Substituted by Corrigendum to Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Official Journal of the European Union L 44 of 18 February 2011).
X5 Substituted by Corrigendum to Commission Regulation (EU) 2020/171 of 6 February 2020 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Official Journal of the European Union L 35 of 7 February 2020).
X6 Substituted by Corrigendum to Commission Regulation (EU) 2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)ether (Official Journal of the European Union L 35 of 10 February 2017).
Textual Amendments
F14 Inserted by Commission Regulation (EU) 2017/999 of 13 June 2017 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F15 Inserted by Commission Regulation (EU) No 143/2011 of 17 February 2011 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Text with EEA relevance).
F16 Substituted by Commission Regulation (EU) 2020/171 of 6 February 2020 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F17 Inserted by Commission Regulation (EU) 2017/999 of 13 June 2017 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F18 Inserted by Commission Regulation (EU) No 125/2012 of 14 February 2012 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) (Text with EEA relevance).
F19 Inserted by Commission Regulation (EU) No 348/2013 of 17 April 2013 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F20 Inserted by Commission Regulation (EU) No 895/2014 of 14 August 2014 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F21 Inserted by Commission Regulation (EU) 2020/171 of 6 February 2020 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F22 Inserted by Commission Regulation (EU) 2020/171 of 6 February 2020 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance).
F23 Inserted by Commission Regulation (EU) No 836/2012 of 18 September 2012 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead (Text with EEA relevance).
F24 Inserted by Commission Regulation (EU) 2015/628 of 22 April 2015 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (‘REACH’) as regards lead and its compounds (Text with EEA relevance).
F25 Inserted by Commission Regulation (EU) 2016/1005 of 22 June 2016 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards asbestos fibres (chrysotile) (Text with EEA relevance).
F26 Inserted by Commission Regulation (EU) 2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)ether (Text with EEA relevance).
The name corresponds to the International Chemical Identification used for the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Whenever possible, substances are designated by their IUPAC names. Substances listed in Einecvs (European Inventory of Existing Commercial Chemical Substances), Elincs (European List of Notified Substances) or the list of ‘ No-longer-polymers ’ are designated using the names in these lists. Other names, such as usual or common names, are included in some cases. Whenever possible, plant protection products and biocides are designated by their ISO names.
A number of group entries are included in Part 3 of Annex VI to Regulation (EC) No 1272/2008. In these cases, the classification requirements will apply to all substances covered by the description.
In some cases, there are classification requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance and the group entry will be annotated with the phrase ‘ except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008 ’ .
In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification will be applied.
The Index number is the identification code given to the substance in Part 3 of Annex VI to Regulation (EC) No 1272/2008. Substances are listed in the Appendix according to this index number.
The EC number, i.e. Einecs, Elincs or NLP, is the official number of the substance within the European Union. The Einecs number can be obtained from the European Inventory of Existing Commercial Chemical Substance (Einecs). The Elincs number can be obtained from the European List of Notified Substances. The NLP number can be obtained from the list of ‘ No-longer-polymers ’ . These lists are published by the Office for Official Publications of the European Communities.
The EC number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (Einecs), at 400-010-9 (Elincs) and at 500-001-0 (NLP). This number is indicated in the column entitled ‘ EC No ’ .
Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification.
The full text of the notes can be found in Part 1 of Annex VI to Regulation (EC) No 1272/2008.
The notes to be taken into account for the purposes of this Regulation are the following:
Note A:
Without prejudice to Article 17(2) of Regulation (EC) No 1272/2008, the name of the substance must appear on the label in the form of one of the designations given in Part 3 of Annex VI to that Regulation.
In that Part, use is sometimes made of a general description such as ‘ … compounds ’ or ‘ … salts ’ . In this case, the supplier who places such a substance on the market is required to state on the label the correct name, due account being taken of Section 1.1.1.4 of Annex VI to Regulation (EC) No 1272/2008.
[X5Note B:
Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and, therefore, these solutions require different classification and labelling since the hazards vary at different concentrations.]
Note C:
Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.
Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
However, such substances are sometimes placed on the market in a non-stabilised form. In this case, supplier who places such a substance on the market must state on the label the name of the substance followed by the words ‘ non-stabilised ’ .
Note J:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EC No 200-753-7).
Note K:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (EC No 203-450-8).
Note L:
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346.
Note M:
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (EC No 200-028-5).
Note N:
The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.
Note P:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EC No 200-753-7).
Note R:
The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm.]
Substances | Index No | EC No | CAS No | Notes |
---|---|---|---|---|
Carbon monoxide | 006-001-00-2 | 211-128-3 | 630-08-0 | |
Lead hexafluorosilicate | 009-014-00-1 | 247-278-1 | 25808-74-6 | |
[X5Slimes and sludges, copper electrolyte refining, decopperised | 028-015-00-8 | 305-433-1 | 94551-87-8 | |
Silicic acid, lead nickel salt | 028-050-00-9 | — | 68130-19-8 | ] |
Lead compounds with the exception of those specified elsewhere in this Annex | 082-001-00-6 | A [F27, E] | ||
Lead alkyls | 082-002-00-1 | A [F27, E] | ||
Lead azide | 082-003-00-7 | 236-542-1 | 13424-46-9 | |
Lead chromate | 082-004-00-2 | 231-846-0 | 7758-97-6 | |
Lead di(acetate) | 082-005-00-8 | 206-104-4 | 301-04-2 | |
Trilead bis(orthophosphate) | 082-006-00-3 | 231-205-5 | 7446-27-7 | |
Lead acetate | 082-007-00-9 | 215-630-3 | 1335-32-6 | |
Lead(II) methanesulphonate | 082-008-00-4 | 401-750-5 | 17570-76-2 | |
C.I. Pigment Yellow 34; (This substance is identified in the Colour Index by Colour Index Constitution No C.I. 77603.) | 082-009-00-X | 215-693-7 | 1344-37-2 | |
C.I. Pigment Red 104; (This substance is identified in the Colour Index by Colour Index Constitution No C.I. 77605.) | 082-010-00-5 | 235-759-9 | 12656-85-8 | |
Lead hydrogen arsenate | 082-011-00-0 | 232-064-2 | 7784-40-9 | |
1,2-Dibromo-3-chloropropane | 602-021-00-6 | 202-479-3 | 96-12-8 | |
2-bromopropane | 602-085-00-5 | 200-855-1 | 75-26-3 | [F27E] |
Warfarin; 4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin | 607-056-00-0 | 201-377-6 | 81-81-2 | |
Lead 2,4,6-trinitroresorcinoxide, lead styphnate | 609-019-00-4 | 239-290-0 | 15245-44-0 |
the label conforming to the specimen below shall be at least 5 cm high (H) and 2,5 cm wide;
it shall consist of two parts:
the top part (h 1 = 40 % H) shall include the letter ‘a’ in white, on a black background,
the bottom part (h 2 = 60 % H) shall include the standard wording in white and/or black, on a red background, and shall be clearly legible;
if the article contains crocidolite, the words ‘ contains asbestos ’ used in the standard wording shall be replaced by ‘ contains crocidolite/blue asbestos ’ .
Member States may exclude from the provision of the first subparagraph articles intended to be placed on the market in their territory. The labelling of these articles must however bear the wording ‘ contains asbestos ’ ;
on each of the smallest units supplied;
if an article has asbestos-based components, it is sufficient for these components only to bear the label. The labelling may be dispensed with if smallness of size or unsuitability of packaging make it impossible for a label to be affixed to the component.
the symbol and relevant indications of danger in accordance with this Annex;
safety instructions which must be selected in accordance with the particulars in this Annex, inasmuch as they are relevant for the particular article.
Where additional safety information is provided on the packaging, this shall not weaken or contradict the particulars given in accordance with points (a) and (b).
a label firmly affixed to the packaging, or
a (tie-on) label securely attached to the package, or
direct printing of the packaging.
For unpackaged articles containing asbestos, labelling in accordance with 3.1 shall be effected by means of:
a label firmly affixed to the article containing asbestos,
a (tie-on) label securely attached to such an article,
direct printing on the articles,
or, if the abovementioned is not reasonably practicable as in the case of, for example, smallness of size of the article, the unsuitable nature of the article's properties or certain technical difficulties by means of a hand-out with labelling in accordance with 3.1.
operate if possible out of doors or in a well-ventilated place,
preferably use hand tools or low-speed tools equipped, if necessary, with an appropriate dust-extraction facility. If high-speed tools are used, they should always be equipped with such a facility,
if possible, dampen before cutting or drilling,
dampen dust and place it in a properly closed receptacle and dispose of it safely.
CAS No | Index No | EC No | Substances | |
---|---|---|---|---|
1. | 92-67-1 | 612-072-00-6 | 202-177-1 | biphenyl-4-ylamine 4-aminobiphenyl xenylamine |
2. | 92-87-5 | 612-042-00-2 | 202-199-1 | benzidine |
3. | 95-69-2 | 202-441-6 | 4-chloro-o-toluidine | |
4. | 91-59-8 | 612-022-00-3 | 202-080-4 | 2-naphthylamine |
5. | 97-56-3 | 611-006-00-3 | 202-591-2 | o-aminoazotoluene 4-amino-2',3-dimethylazobenzene 4-o-tolylazo-o-toluidine |
6. | 99-55-8 | 202-765-8 | 5-nitro-o-toluidine | |
7. | 106-47-8 | 612-137-00-9 | 203-401-0 | 4-chloroaniline |
8. | 615-05-4 | 210-406-1 | 4-methoxy-m-phenylenediamine | |
9. | 101-77-9 | 612-051-00-1 | 202-974-4 | 4,4'-methylenedianiline 4,4'-diaminodiphenylmethane |
10. | 91-94-1 | 612-068-00-4 | 202-109-0 | 3,3'-dichlorobenzidine 3,3'-dichlorobiphenyl-4,4'-ylenediamine |
11. | 119-90-4 | 612-036-00-X | 204-355-4 | 3,3'-dimethoxybenzidine o-dianisidine |
12. | 119-93-7 | 612-041-00-7 | 204-358-0 | 3,3'-dimethylbenzidine 4,4'-bi-o-toluidine |
13. | 838-88-0 | 612-085-00-7 | 212-658-8 | 4,4'-methylenedi-o-toluidine |
14. | 120-71-8 | 204-419-1 | 6-methoxy-m-toluidine p-cresidine | |
15. | 101-14-4 | 612-078-00-9 | 202-918-9 | 4,4'-methylene-bis-(2-chloro-aniline) 2,2'-dichloro-4,4'-methylene-dianiline |
16. | 101-80-4 | 202-977-0 | 4,4'-oxydianiline | |
17. | 139-65-1 | 205-370-9 | 4,4'-thiodianiline | |
18. | 95-53-4 | 612-091-00-X | 202-429-0 | o-toluidine 2-aminotoluene |
19. | 95-80-7 | 612-099-00-3 | 202-453-1 | 4-methyl-m-phenylenediamine |
20. | 137-17-7 | 205-282-0 | 2,4,5-trimethylaniline | |
21. | 90-04-0 | 612-035-00-4 | 201-963-1 | o-anisidine 2-methoxyaniline |
22. | 60-09-3 | 611-008-00-4 | 200-453-6 | 4-amino azobenzene |
CAS No | Index No | EC No | Substances | |
---|---|---|---|---|
1. | Not allocated Component 1: CAS-No: 118685-33-9 C 39 H 23 ClCrN 7 O 12 S.2Na Component 2: C 46 H 30 CrN 10 O 20 S 2 .3Na | 611-070-00-2 | 405-665-4 | A mixture of: disodium (6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)(1-(5-chloro-2-oxidophenylazo)-2-naphtholato)chromate(1-); trisodium bis(6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxidophenylazo)-1-naphtholato)chromate(1-) |
European standardisation organisation | Reference and title of the harmonised standard | Reference of the superseded standard |
---|---|---|
CEN | EN ISO 17234-1:2010 Leather — Chemical tests for the determination of certain azo colorants in dyed leathers — Part 1: Determination of certain aromatic amines derived from azo colorants | CEN ISO/TS 17234:2003 |
CEN | EN ISO 17234-2:2011 Leather — Chemical tests for the determination of certain azo colorants in dyed leathers — Part 2: Determination of 4-aminoazobenzene | CEN ISO/TS 17234:2003 |
CEN | EN 14362-1:2012 Textiles — Methods for determination of certain aromatic amines derived from azo colorants — Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres | EN 14362-1:2003 EN 14362-2:2003 |
CEN | EN 14362-3:2012 Textiles — Methods for determination of certain aromatic amines derived from azo colorants — Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene | ] |
a | |
Substances | Derogations |
---|---|
1.(a) Sodium perborate; perboric acid, sodium salt; perboric acid, sodium salt, monohydrate; sodium peroxometaborate; perboric acid (HBO(O 2 )), sodium salt, monohydrate; sodium peroxoborate CAS No 15120-21-5; 11138-47-9; 12040-72-1; 7632-04-4; 10332-33-9 EC No 239-172-9; 234-390-0; 231-556-4 (b) Perboric acid (H 3 BO 2 (O 2 )), monosodium salt trihydrate; perboric acid, sodium salt, tetrahydrate; perboric acid (HBO(O 2 )), sodium salt, tetrahydrate; sodium peroxoborate hexahydrate CAS No 13517-20-9; 37244-98-7; 10486-00-7 EC No 239-172-9; 234-390-0; 231-556-4 | Detergents as defined by Regulation (EC) No 648/2004 of the European Parliament and of the Council a . The derogation shall apply until 1 June 2013 . |
[X1In general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the assessment factor. An assessment factor of 1 000 is typically applied to the lowest of three short term L(E)C50 values derived from species representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from species representing different trophic levels.]
[X1 [F4 OJ L 39, 15.2.1980, p. 40 .] ]
[X1 [F4 OJ L 188, 9.8.1995, p. 14 .] ]
[X1 [F4 OJ L 399, 30.12.1989, p. 18 .] ]
[X1 [F4 OJ L 312, 22.11.2008, p. 3 .] ]
[X1 [F4United Nations, Economic Commission for Europe, version applicable as from 1 January 2009 , ISBN-978-92-1-139131-2.] ]
[X1 [F4Annex 1 to Appendix B (Uniform Rules concerning the Contract for International Carriage of Goods by Rail) of the Convention concerning International Carriage by Rail, version with effect from 1 January 2009 .] ]
[X1 [F4 OJ L 260, 30.9.2008, p. 1 .] ]
[X1 [F4MEPC.2/Circular, Provisional categorisation of liquid substances, version 14, effective 1 January 2009 .] ]
[X1 [F4 OJ L 244, 29.9.2000, p. 1 .] ]
[X1 [F4 OJ L 158, 30.4.2004, p. 7 .] ]
[X1 [F4 OJ L 204, 31.7.2008, p. 1 .] ]
[X1 [F4 OJ L 10, 14.1.1997, p. 13 .] ]
[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]
[X1Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.]
[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]
[X1Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.]
[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]
[X1Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.]
[X1This Annex shall apply to producers of articles that are required to register in accordance with Article 7 and to other downstream users that are required to carry out tests under this Regulation adapted as necessary.]
[X1Note: conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test methods as specified in Article 13(3) that are not repeated in column 2, also apply.]
[X1 [F6For the purpose of subparagraph 3.2(a)(ii), without prejudice to column 2 of Section 8.7 of Annexes IX and X, a DNEL derived from a screening test for reproductive/developmental toxicity shall not be considered appropriate to omit a prenatal developmental toxicity study or a two-generation reproductive toxicity study. For the purpose of subparagraph 3.2(a)(ii), without prejudice to column 2 of section 8.6 of Annexes IX and X, a DNEL derived from a 28-day repeated dose toxicity study shall not be considered appropriate to omit a 90-day repeated dose toxicity study.] ]
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).
Textual Amendments
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