- Latest available (Revised)
- Point in Time (12/10/2008)
- Original (As adopted by EU)
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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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).
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.
If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB, the chemical safety assessment shall also consider the following steps:
Exposure assessment
The generation of exposure scenario(s) or the generation of relevant use and exposure categories if appropriate.
Exposure estimation.
Risk characterisation
A summary of all the relevant information used in addressing the points above, shall be presented under the relevant heading of the Chemical Safety Report (Section 7).
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.
to determine the classification and labelling of a substance in accordance with Directive 67/548/EEC, and
to derive levels of exposure to the substance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (DNEL).
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Evaluation of non-human information.
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Evaluation of human information.
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Classification and Labelling.
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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 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 are inadequate to decide whether a substance should be classified for a particular end-point, the registrant shall indicate and justify the action or decision he has taken as a result.
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Evaluation of information.
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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.
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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, which is submitted as part of the technical dossier, with the criteria given in Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria.
If the available information is not sufficient to decide whether the substance fulfils the criteria in Annex XIII, then other evidence like monitoring data available for the registrant and giving rise to an equivalent level of concern shall be considered on a case-by-case basis.
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 and T properties to decide whether further information needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the generation of further information is necessary and would require testing on vertebrate animals, the registrant shall submit a testing proposal. However, such further information does not need to be generated if the registrant implements or recommends sufficient risk management measures and operational conditions that enable derogation according to Section 3 of Annex XI from testing relevant for PBT and vPvB assessment.
If the substance fulfils the criteria 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:
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Generation of exposure scenario(s) or the generation of relevant use and exposure categories.
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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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10.x.1.1.
10.x.2.1.
This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accordance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report has been performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to them under the relevant headings of the Safety Data Sheet easier.
The purpose of this Annex is to ensure consistency and accuracy in the content of each of the mandatory headings listed in Article 31, so that the resulting Safety Data Sheets will enable users to take the necessary measures relating to protection of human health and safety at the workplace, and protection of the environment.
The information provided by Safety Data Sheets shall also meet the requirements set out in Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. In particular, the Safety Data Sheet shall enable the employer to determine whether any hazardous chemical agents are present in the workplace, and to assess any risk to the health and safety of workers arising from their use.
The information in the Safety Data Sheet shall be written in a clear and concise manner. The Safety Data Sheet shall be prepared by a competent person who shall take into account the specific needs of the user audience, as far as it is known. Persons placing substances and preparations on the market shall ensure that competent persons have received appropriate training, including refresher training.
For preparations not classified as dangerous, but for which a Safety Data Sheet is required according to Article 31, proportionate information shall be provided under each heading.
Additional information may be necessary in some cases in view of the wide range of properties of the substances and preparations. If in other cases it emerges that information on certain properties is of no significance or that it is technically impossible to provide, the reasons for this shall be clearly stated under each heading. Information shall be provided for each hazardous property. If it is stated that a particular hazard does not apply, clearly differentiate between cases where no information is available to the classifier, and cases where negative test results are available.
Give the date of issue of the Safety Data Sheet on the first page. When a safety data sheet has been revised, the changes shall be brought to the attention of the recipient and identify it as ‘ Revision: (date) ’ .
Safety data sheets are also required for certain special substances and preparations (e.g. metals in massive form, alloys, compressed gases, etc.) listed in chapters 8 and 9 of Annex VI to Directive 67/548/EEC, for which there are labelling derogations.
The term used for identification shall be identical to that provided on the label as set out in Annex VI to Directive 67/548/EEC.
For substances subject to registration, the term shall be consistent with that provided under registration and the registration number assigned under Article 20(1) of this Regulation shall also be indicated.
Other means of identification available may also be indicated.
Indicate the uses of the substance or preparation as far as they are known. Where there are many possible uses, only the most important or common uses need to be listed. This shall include a brief description of what it actually does, e.g. flame retardant, anti-oxidant, etc.
Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet.
Identify the person responsible for placing the substance or preparation on the market within the Community, whether it is the manufacturer, importer or distributor. Give the full address and telephone number of this person as well as the e-mail address of the competent person responsible for the Safety Data Sheet.
In addition, where this person is not located in the Member State where the substance or preparation is placed on the market, give a full address and telephone number for the person responsible in that Member State, if possible.
For registrants, the person identified shall be consistent with the information on the identity of the manufacturer or importer provided in the registration.
In addition to the above mentioned information, supply the emergency telephone number of the company and/or relevant official advisory body (this may be the body responsible for receiving information relating to health, which is referred to in Article 17 of Directive 1999/45/EC). Specify if this phone number is available only during office hours.
Give here the classification of the substance or preparation which arises from application of the classification rules in Directives 67/548/EEC or 1999/45/EC. Indicate clearly and briefly the hazards the substance or preparation presents to man and the environment.
Distinguish clearly between preparations which are classified as dangerous and preparations which are not classified as dangerous according to Directive 1999/45/EC.
Describe the most important adverse physicochemical, human health and environmental effects and symptoms relating to the uses and possible misuses of the substance or preparation that can reasonably be foreseen.
It may be necessary to mention other hazards, such as dustiness, cross-sensitisation, suffocation, freezing, high potency for odour or taste or environmental effects such as hazards to soil-dwelling organisms, ozone depletion, photochemical ozone creation potential, etc., which do not result in classification but which may contribute to the overall hazards of the material.
The information shown on the label shall be given under heading 15.
The classification of the substance shall be consistent with the classification provided to the classification and labelling inventory according to Title XI.
The information given shall enable the recipient to identify readily the hazards of the components of the preparation. The hazards of the preparation itself shall be given under heading 2.
substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they are present in concentrations equal to or greater than the lowest of:
the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC, or
the concentration limits given in Annex I to Directive 67/548/EEC, or
the concentration limits given in Part B of Annex II to Directive 1999/45/EC, or
the concentration limits given in Part B of Annex III Directive 1999/45/EC, or
the concentration limits given in Annex V to Directive 1999/45/EC, or
the concentration limits given in an agreed entry in the classification and labelling inventory established under Title XI of this 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, if the concentration of an individual substance is equal to or greater than 0,1 %.
≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations and
the substances present a health or environmental hazard within the meaning of Directive 67/548/EEC (2) , or
the substances are assigned Community workplace exposure limits, or
≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII.
Describe the first-aid measures.
Specify first whether immediate medical attention is required.
The information on first aid shall be brief and easy to understand by the victim, bystanders and first-aiders. The symptoms and effects shall be briefly summarised. The instructions shall indicate what is to be done on the spot in the case of an accident and whether delayed effects can be expected after exposure.
Subdivide the information according to the different routes of exposure, i.e. inhalation, skin and eye contact and ingestion, under different subheadings.
Indicate whether professional assistance by a doctor is needed or advisable.
For some substances or preparations it may be important to emphasise that special means to provide specific and immediate treatment shall be available at the workplace.
Refer to requirements for fighting a fire caused by the substance or preparation, or arising in its vicinity by indicating:
suitable extinguishing media,
extinguishing media which shall not be used for safety reasons,
special exposure hazards arising from the substance or preparation itself, combustion products, resulting gases,
special protective equipment for fire-fighters.
Depending on the substance or preparation involved, information may be needed on:
personal precautions such as:
removal of ignition sources, provision for sufficient ventilation/respiratory protection, control of dust, prevention of skin and eye contact,
environmental precautions such as:
keeping away from drains, surface- and ground-water and soil, possible need to alert the neighbourhood,
methods for cleaning up such as:
use of absorbent material (e.g. sand, diatomaceous earth, acid binder, universal binder, sawdust, etc.), reduction of gases/fumes with water, dilution.
Also consider the need for indications such as: ‘ never use, neutralise with ... ’ .
If appropriate refer to headings 8 and 13.
Information in this section 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.
Where a chemical safety report or a registration is required, the information in this section shall be consistent with the information given, for the identified uses and exposure scenarios set out in the annex to the Safety Data Sheet.
Specify precautions for safe handling including advice on technical measures such as:
containment, local and general ventilation, measures to prevent aerosol and dust generation and fire, measures required to protect the environment (e.g. use of filters or scrubbers on exhaust ventilation, use in a bunded area, measures for collection and disposal of spillages, etc.) and any specific requirements or rules relating to the substance or preparation (e.g. procedures or equipment which are prohibited or recommended) and if possible give a brief description.
Specify the conditions for safe storage such as:
specific design for storage rooms or vessels (including retention walls and ventilation), incompatible materials, conditions of storage (temperature and humidity limit/range, light, inert gas, etc.) special electrical equipment and prevention of static electricity.
Give advice if relevant on quantity limits under storage conditions. In particular indicate any special requirements such as the type of material used in the packaging/containers of the substance or preparation.
For end products designed for specific use(s), recommendations shall refer to the identified use(s) and be detailed and operational. If possible, reference shall be made to industry- or sector-specific approved guidance.
Specify currently applicable specific control parameters including occupational exposure limit values and/or biological limit values. Values shall be given for the Member State where the substance or preparation is placed on the market. Give information on currently recommended monitoring procedures.
Where a Chemical Safety Report is required, the relevant DNELs and PNECs for the substance shall be given for the exposure scenarios set out in the annex to the Safety Data Sheet.
For preparations, it is useful to provide values for those constituent substances which are required to be listed in the Safety Data Sheet according to heading 3.
For the purposes of this document exposure control means the full range of specific risk management measures to be taken during use in order to minimise worker and environmental exposure. Where a chemical safety report is required, a summary of the risk management measures shall be given in Section 8 of the Safety Data Sheet for the identified uses set out in the Safety Data Sheet.
This information will be taken into account by the employer in carrying out an assessment of risk to the health and safety of workers for the substance or preparation under Article 4 of Directive 98/24/EC, which requires, in the order of priority:
design of appropriate work processes and engineering controls, the use of adequate equipment and materials,
the application of collective protection measures at source, such as adequate ventilation and appropriate organisational measures, and
where exposure cannot be prevented by other means the use of individual protection measures, such as personal protection equipment.
Therefore provide suitable and adequate information on these measures to enable a proper risk assessment to be carried out under Article 4 of Directive 98/24/EC. This information shall complement that already given under heading 7.1.
Where individual protection measures are needed, specify in detail which equipment will provide adequate and suitable protection. Take into account Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (3) and make reference to the appropriate CEN standards:
Respiratory protection
For dangerous gases, vapours or dust, specify the type of protective equipment to be used, such as:
self contained breathing apparatus, adequate masks and filters.
Hand protection
Specify clearly the type of gloves to be worn when handling the substance or preparation, including:
the type of material,
the breakthrough time of the glove material, with regard to the amount and duration of dermal exposure.
If necessary indicate any additional hand protection measures.
Eye protection
Specify the type of eye protection equipment required such as:
safety glasses, safety goggles, face shield.
Skin protection
If it is necessary to protect a part of the body other than the hands, specify the type and quality of protection equipment required, such as:
apron, boots and full protective suit.
If necessary, indicate any additional skin protection measures and specific hygiene measures.
Specify the information required by the employer to fulfil his commitments under Community environmental protection legislation.
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.
To enable proper control measures to be taken, provide all relevant information on the substance or preparation, particularly the information listed under heading 9.2. The information in this section shall be consistent with the information provided in a registration where one is required.
indicate the physical state (solid, liquid, gas) and the colour of the substance or preparation as supplied.
if odour is perceptible, give a brief description of it.
pH:
indicate the pH of the substance or preparation as supplied or of an aqueous solution; in the latter case, indicate the concentration.
Boiling point/boiling range
Flash point
Flammability (solid, gas)
Explosive properties
Oxidising properties
Vapour pressure
Relative density
Solubility
Water solubility
Partition coefficient: n-octanol/water
Viscosity
Vapour density
Evaporation rate
Indicate other important safety parameters, such as miscibility, fat solubility (solvent — oil to be specified), conductivity, melting point/melting range, gas group (useful for Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres (4) ), auto-ignition temperature, etc.
The above properties shall be determined in accordance with the specifications laid down in the Commission Regulation on testing methods referred to in Article 13(3) or any other comparable method.
For preparations, information shall normally be given on the properties of the preparation itself. However, if it is stated that a particular hazard does not apply, clearly differentiate between cases where no information is available to the classifier, and cases where negative test results are available. If it is considered necessary to give information about the properties of individual components, please indicate clearly what the data refers to.
State the stability of the substance or preparation and the possibility of hazardous reactions occurring under certain conditions of use and also if released into the environment.
List those conditions such as temperature, pressure, light, shock, etc., which may cause a dangerous reaction and if possible give a brief description.
List materials such as water, air, acids, bases, oxidising agents or any other specific substance which may cause a dangerous reaction and if possible give a brief description.
List hazardous materials produced in dangerous amounts upon decomposition.
Address specifically:
the need for and the presence of stabilisers,
the possibility of a hazardous exothermic reaction,
safety significance, if any, of a change in physical appearance of the substance or preparation,
hazardous decomposition products, if any, formed upon contact with water,
possibility of degradation to unstable products.
This section deals with the need for a concise but complete and comprehensible description of the various toxicological (health) effects, which can arise if the user comes into contact with the substance or preparation.
The information shall include dangerous-to-health effects from exposure to the substance or preparation, based on the conclusion from, for example, test data and experience. The information shall also include, where appropriate, delayed, immediate and chronic effects from short- and long-term exposure such as sensitisation, narcosis, carcinogenicity, mutagenicity and reproductive toxicity (developmental toxicity and fertility). It shall also include information on the different routes of exposure (inhalation, ingestion, skin and eye contact), and describe the symptoms related to the physical, chemical and toxicological characteristics.
Taking account of the information already provided under heading 3, composition/information on ingredients, it may be necessary to make reference to specific health effects of certain substances in the preparation.
The information in this section shall be consistent with the information provided for in a registration where required and/or in a Chemical Safety Report where required and shall give information on the following groups of potential effects:
toxicokinetics, metabolism and distribution,
acute effects (acute toxicity, irritation and corrosivity),
sensitisation,
repeated dose toxicity, and
CMR effects (carcinogenity, mutagenicity and toxicity for reproduction).
For substances subject to registration, summaries of the information derived from the application of Annexes VII to XI of this Regulation shall be given. The information shall also include the result of the comparison of the available data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following paragraph 1.3.1 of Annex I of this Regulation.
Describe the possible effects, behaviour and environmental fate of the substance or preparation in air, water and/or soil. Where available, give relevant test data (e.g. LC50 fish ≤ 1 mg/l).
The information in this section shall be consistent with the information provided for in a registration where required and/or in a Chemical Safety Report where required.
Describe the most important characteristics likely to have an effect on the environment owing to the nature of the substance or preparation and likely methods of use. Information of the same kind shall be supplied for dangerous products arising from the degradation of substances and preparations. This may include the following:
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 macro-organisms and other environmentally relevant organisms, such as birds, bees and plants, shall be included when available. Where the substance or preparation has inhibitory effects on the activity of micro-organisms, 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.
The potential of the substance or the appropriate constituents of a preparation (5) , if released to the environment, to transport to groundwater or far from the site of release.
Relevant data might include:
known or predicted distribution to environmental compartments,
surface tension,
absorption/desorption.
For other physicochemical properties see heading 9.
The potential of the substance or the appropriate constituents of a preparation (5) to degrade in relevant environmental media, either through biodegradation or other processes such as oxidation or hydrolysis. Degradation half lives shall be quoted where available. The potential of the substance or appropriate constituents of a preparation (5) to degrade in sewage treatment plants shall also be mentioned.
The potential of the substance or the appropriate constituents of a preparation (5) to accumulate in biota and, eventually, to pass through the food chain, with reference to the octanol-water partition coefficient (Kow) and bioconcentration factor (BCF), if available.
Where a Chemical Safety Report is required, the results of the PBT assessment as set in the Chemical Safety Report shall be given.
If available, include information on any other adverse effects on the environment, e.g. ozone depletion potential, photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.
Ensure that information relevant to the environment is provided under other headings of the Safety Data Sheet, especially advice for controlled release, accidental release measures, transport and disposal considerations under headings 6, 7, 13, 14 and 15.
If the disposal of the substance or preparation (surplus or waste resulting from the foreseeable use) presents a danger, a description of these residues and information on their safe handling shall be given.
Specify the appropriate methods of disposal of both the substance or preparation and any contaminated packaging (incineration, recycling, landfilling, etc.)
Where a Chemical Safety Report is required, the information on the waste management measures that adequately control exposure of humans and the environment to the substance shall be consistent with the exposure scenarios set out in the annex to the Safety Data Sheet.
Refer to any relevant Community provisions relating to waste. In their absence, it is useful to remind the user that national or regional provisions may be in force.
Indicate any special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside his premises. Where relevant, provide information on the transport classification for each of the modal regulations: IMDG (sea), ADR (Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (6) ), RID (Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (7) ), ICAO/IATA (air). This might include inter alia :
UN number,
class,
proper shipping name,
packing group,
marine pollutant,
other applicable information.
Indicate if a Chemical Safety Assessment has been carried out for the substance (or a substance in the preparation).
Give the health, safety and environmental information shown on the label according to Directives 67/548/EEC and 1999/45/EC.
If the substance or preparation covered by this safety data sheet is the subject of specific provisions in relation to protection of man or the environment at Community level (e.g. authorisations given under Title VII or restrictions under Title VIII) these provisions shall, as far as is possible, be stated.
Also mention, where possible, the national laws which implement these provisions and any other national measures that may be relevant.
Indicate any other information which the supplier assesses as being of importance for the health and safety of the user and for the protection of the environment, for example:
list of relevant R phrases. Write out the full text of any R phrases referred to under headings 2 and 3 of the Safety Data Sheet,
training advice,
recommended restrictions on use (i.e. non-statutory recommendations by supplier),
further information (written references and/or technical contact point),
sources of key data used to compile the Safety Data Sheet.
For a revised Safety Data Sheet, indicate clearly the information, which has been added, deleted or revised (unless this has been indicated elsewhere).
Criteria for substances registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):
substances for which it is predicted (ie by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1 or 2 classification for carcinogenicity, 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 preparations or incorporated into consumer articles; and
for 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 human health or environmental effects endpoints under Directive 67/548/EEC.
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).
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 an endpoint 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 (9) .
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 (11) .
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.
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 (13) .
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.
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 (15) .
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.
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 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 preparation 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.
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).
A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substances, but shall apply to organo-metals.
A substance that fulfils all three of the criteria of the sections below is a PBT substance.
A substance fulfils the persistence criterion (P-) when:
the half-life in marine water is higher than 60 days, or
the half-life in fresh- or estuarine water is higher than 40 days, or
the half-life in marine sediment is higher than 180 days, or
the half-life in fresh- or estuarine water sediment is higher than 120 days, or
the half-life in soil is higher than 120 days.
The assessment of the persistency in the environment shall be based on available half-life data collected under the adequate conditions, which shall be described by the registrant.
A substance fulfils the bioaccumulation criterion (B-) when:
the bioconcentration factor (BCF) is higher than 2 000 .
The assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data from freshwater as well as marine water species can be used.
A substance fulfils the toxicity criterion (T-) when:
the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is less than 0,01 mg/l, or
the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or
there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.
A substance that fulfils the criteria of the sections below is a vPvB substance.
A substance fulfils the very persistence criterion (vP-) when:
the half-life in marine, fresh- or estuarine water is higher than 60 days, or
the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or
the half-life in soil is higher than 180.
A substance fulfils the very bioaccumulative criterion (vB-) when:
the bioconcentration factor is greater than 5 000 .
This Annex lays down general principles for preparing dossiers to propose and justify:
harmonised classification and labelling of CMRs, respiratory sensitisers and other effects,
the identification of PBTs, vPvBs, or a substance of equivalent concern,
restrictions of the manufacture, placing on the market or use of a substance within the Community.
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 the substance(s) concerned and the harmonised classification and labelling proposed.
A comparison of the available information with the criteria for CMRs, respiratory sensitisers and other effects on a case by case basis in Directive 67/548/EEC according to the relevant parts of Section 1 of Annex I shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I.
Justification shall be provided that there is a need for action demonstrated at Community Level.
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.
a OJ L 377, 31.12.1991, p. 20 . Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council ( OJ L 33, 4.2.2006, p. 1 ). | |
b Chrysotile has two CAS Nos, confirmed by ECB. | |
c Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff ( OJ L 256, 7.9.1987 ). Regulation as last amended by Regulation (EC) No 426/2006 ( OJ L 79, 16.3.2006, p. 1 ). | |
d OJ L 147, 9.6.1975, p. 40 . Directive as last amended by Regulation (EC) No 807/2003 ( OJ L 122, 16.5.2003, p. 36 ). | |
e For the purposes of this point ‘ childcare article ’ shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. | |
Designation of the substance, of the groups of substances or of the preparation | Conditions of restriction |
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1. Polychlorinated terphenyls (PCTs)
| 1. Shall not be used. However, the following use of equipment, installations and fluids which were in service on 30 June 1986 shall continue to be permitted until they are disposed of or reach the end of their service life:(a) closed-system electrical equipment transformers, resistors and inductors; (b) large condensers (≥ 1 kg total weight); (c) small condensers; (d) heat-transmitting fluids in closed-circuit heat-transfer installations; (e) hydraulic fluids for underground mining equipment. 2. The Member State may, for reasons of protection of human health and the environment, prohibit the use of equipment, installations and fluids covered by paragraph 1 before they are disposed of or reach the end of their service life.3. The placing on the second-hand market of equipment, plant and fluids covered by paragraph 1 which are not intended for disposal shall be prohibited.4. Where the Member State considers that it is not possible for technical reasons to use substitute articles, it may permit the use of PCTs and preparations thereof where the latter are solely intended, in the normal conditions of maintenance of equipment, to supplement the level of liquids containing PCTs in properly functioning existing installations purchased before 1 October 1985 .5. The Member State may, provided prior notification stating the reasons is sent to the Commission, grant derogations from the ban on the placing on the market and use of primary and intermediate substances or preparations, in so far as they consider that these derogations have no deleterious effects on human health and the environment.6. Without prejudice to the implementation of other Community provisions relating to the labelling of dangerous substances and preparations, equipment and installations containing PCTs must also display instructions concerning the disposal of PCTs and the maintenance and use of equipment and installations containing them. These instructions must be capable of being read horizontally when the object containing the PCTs is installed in the normal way. The inscription must stand out clearly from its background and shall be in a language which is understood in the territory where it is being used. |
2. Chloro-1-ethylene (monomer vinyl chloride)CAS No 75-01-4 EINECS No 200-831-0 | Shall not be used as aerosol propellant for any use. |
3. Liquid substances or preparations, which are regarded as dangerous according to the definitions in Council Directive 67/548/EEC and Directive 1999/45/EC. | 1. Shall not be used in:
2. Without prejudice to paragraph 1, substances and preparations which:
shall not contain a colouring agent, unless required for fiscal reasons, or perfume or both. 3. Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraph 2, where intended for use in lamps, must be marked legibly and indelibly as follows:‘ Keep lamps filled with this liquid out of the reach of children ’ . |
4. Tris (2,3 dibromopropyl) phosphateCAS No 126-72-7 | Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin. |
5. BenzeneCAS No 71-43-2 EINECS No 200-753-785 | 1. Not permitted in toys or parts of toys as placed on the market where the concentration of benzene in the free state is in excess of 5 mg/kg of the weight of the toy or part of toy.2. Shall not be used in concentrations equal to, or greater than, 0,1 % by mass in substances or preparations placed on the market.3. However, paragraph 2 shall not apply to:(a) motor fuels which are covered by Directive 98/70/EC; (b) substances and preparations for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation; (c) waste covered by Council Directive 91/689/EEC of 12 December 1991 on hazardous waste a and Directive 2006/12/EC. |
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 | 1. The placing on the market and use of these fibres and of articles containing these fibres added intentionally shall be prohibited.However, Member States may except 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. The Commission will review this derogation before 1 January 2008 . 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, prohibit the use of such articles before they are disposed of or reach the end of their service life.Member States shall not permit the introduction of new applications for chrysotile asbestos on their territories. 3. Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the placing on the market and use of these fibres and of articles containing these fibres, as permitted according to the preceding derogations, shall be permitted only if the articles bear a label in accordance with the provisions of Appendix 7 to this Annex. |
7. Tris(aziridinyl)phosphinoxideCAS No 5455-55-1 | Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin. |
8. Polybromobiphenyls; Polybrominatedbiphenyls (PBB)CAS No 59536-65-1 | |
9. Soap bark powder (Quillaja saponaria) and its derivatives containing saponinesPowder of the roots of Helleborus viridis and Helleborus niger Powder of the roots of Veratrum album and Veratrum nigrum Benzidine and/or its derivatives CAS No 92-87-5 EINECS No 202-199-1 o -Nitrobenzaldehyde CAS No 552-89-6 Wood powder | 1. Shall not be used in jokes and hoaxes or in objects intended to be used as such, for instance as a constituent of sneezing powder and stink bombs.2. However, paragraph 1 does not apply to stink bombs containing not more than 1,5 ml of liquid. |
10. Ammonium sulphideCAS No 12135-76-1 Ammonium hydrogen sulphide CAS No 12124-99-1 Ammonium polysulphide CAS No 9080-17-5 EINECS No 232-989-1 | |
11. Volatile esters of bromoacetic acids:
| |
12. 2-NaphthylamineCAS No 91-59-8 EINECS No 202-080-4 and its salts 13. BenzidineCAS No 92-87-5 EINECS No 202-199-1 and its salts 14. 4-NitrobiphenylCAS No 92-93-3 EINECS No 202-204-7 15. 4-Aminobiphenyl xenylamineCAS No 92-67-1 EINECS No 202-177-1 and its salts | 1. Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market.However, this provision shall not apply to waste containing one or more of these substances and covered by Directives 91/689/EEC and 2006/12/EC. 2. Such substances and preparations shall not be sold to the general public.3 Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, the packaging of such preparations shall be legible and indelibly marked as follows:‘Restricted to professional users’ . |
16. Lead carbons:(a) Neutral anhydrous carbonate (PbCO 3 ) CAS No 598-63-0 EINECS No 209-943-4 (b) Trilead-bis(carbonate)-dihydroxide 2 Pb CO 3 -Pb(OH) 2 CAS No 1319-46-6 EINECS No 215-290-6 | Shall not be used as substances and a constituent of preparations intended for use as paints, except for the restoration and maintenance of works of art and historic buildings and their interiors, where Member States wish to permit this on their territory, in accordance with the provisions of ILO Convention 13 on the use of white lead and sulphates of lead in paint. |
17. Lead sulphates(a) PbSO 4 (1:1) CAS No 7446-14-2 EINECS No 231-198-9 (b) Pb x SO 4 CAS No 15739-80-7 EINECS No 239-831-0 | |
18. Mercury compounds | 1. Shall not be used as substances and constituents of preparations 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. 2. The placing on the market of batteries and accumulators, containing more than 0,0005 % of mercury by weight, including in those cases where these batteries and accumulators are incorporated into appliances shall be prohibited. Button cells and batteries composed of button cells with a mercury content of no more than 2 % by weight shall be exempted from this prohibition. |
19. Arsenic compounds | 1. Shall not be used as substances and constituents of preparations intended for use:(a) to prevent the fouling by micro-organisms, plants or animals of:
(b) in the preservation of wood. Furthermore, wood so treated shall not be placed on the market; (c) however, by way of derogation: (i) Relating to the substances and preparations in 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. Wood so treated shall not be placed on the market before fixation of the preservative is completed. (ii) Relating to wood treated with CCA solutions in industrial installations according to point (i): this 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:
Without prejudice to the application of other Community provisions on the classification, packaging and labelling of dangerous substances and preparations, all treated wood placed on the market shall be 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 ’ . (iii) Treated wood referred to under points (i) and (ii) shall not be used:
2. Shall not be used as substances and constituents of preparations intended for use in the treatment of industrial waters, irrespective of their use. |
20. Organostannic compounds | 1. Shall not be placed on the market for use as substances and constituents of preparations when acting as biocides in free association paint.2. Shall not be placed on the market or used as substances and constituents of preparations which act as biocides 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 used as substances and constituents of preparations intended for use in the treatment of industrial waters. |
21. Di-μ-oxo-di-n-butylstanniohydroxyborane dibutyltin hydrogen borate C 8 H 19 BO 3 S n (DBB)CAS No 75113-37-0 ELINCS No 401-040-5 | Shall be prohibited in a concentration equal to or greater than 0,1 % in substances and constituents of preparations placed on the market. However, this provision shall not apply to this substance (DBB) or preparations containing it if these are intended solely for conversion into finished 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 EINECS No 201-778-6 and its salts and esters | 1. Shall not be used in a concentration equal to or greater than 0,1 % by mass in substances or preparations placed on the market.2. Transitional provisions:By way of derogation until 31 December 2008 France, Ireland, Portugal, Spain and the United Kingdom may chose not to apply this provision to substances and preparations intended for use in industrial installations not permitting the emission and/or discharge of pentachlorophenol (PCP) in quantities greater than those prescribed by existing legislation: (a) in the treatment of wood. However, treated wood shall not be used:
(b) in the impregnation of fibres and heavy-duty textiles not intended in any case for clothing or for decorative furnishings; (c) by way of special exception, Member States may on a case-by-case basis, permit on their territory specialised professionals to carry out in situ and for buildings of cultural, artistic and historical interest, or in emergencies, a remedial treatment of timber and masonry infected by dry rot fungus (Serpula lacrymans) and cubic rot fungi. In any case: (a) Pentachlorophenol used alone or as a component of preparations employed within the framework of the above exceptions must have a total hexachlorodibenzoparadioxin (HCDD) content of not more than two parts per million (ppm); (b) these substances and preparations shall not:
3. Without prejudice to the implementation of other Community provisions concerning the classification, packaging and labelling of dangerous substances and preparations, the packaging of substances and preparations covered by paragraphs 1 and 2 shall be marked clearly and indelibly:‘ Reserved for industrial and professional use ’ . This provision shall not apply to waste covered by Directives 91/689/EEC and 2006/12/EC. |
23. CadmiumCAS No 7440-43-9 EINECS No 231-152-8 and its compounds | 1. Shall not be used to give colour to finished articles manufactured from the substances and preparations listed below:(a)
(b) paints [ 3208 ] [ 3209 ] c . However, if the paints have a high zinc content, their residual concentration of cadmium shall be as low as possible and shall at all events not exceed 0,1 % by mass. In any case, whatever their use or intended final purpose, finished articles or components of articles manufactured from the substances and preparations listed above coloured with cadmium shall not be placed on the market if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the plastic material. 2. However, paragraph 1 does not apply to articles to be coloured for safety reasons.3. Shall not be used to stabilise the finished articles listed below manufactured from polymers or copolymers of vinyl chloride:
In any case, whatever their use or intended final purpose, the placing on the market of the above finished articles or components of articles manufactured from polymers or copolymers of vinyl chloride, stabilised by substances containing cadmium shall be prohibited, if their cadmium content (expressed as Cd metal) exceeds 0,01 % by mass of the polymer. 4. However, paragraph 3 does not apply to finished articles using cadmium-based stabilisers for safety reasons.5. Within the meaning of this Regulation, ‘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 sectors/applications listed below: (a) equipment and machinery for: 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 shall be prohibited. 6. The provisions referred to in paragraph 5 are also 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: 7. However, the restrictions in paragraphs 5 and 6 do not apply to:
Owing to the development of knowledge and techniques in respect of substitutes less dangerous than cadmium and its compounds, the Commission shall, in consultation with the Member States, assess the situation at regular intervals in accordance with the procedure laid down in Article 133(3) of this Regulation. |
24. Monomethyl — tetrachlorodiphenyl methaneTrade name: Ugilec 141 CAS No 76253-60-6 | 1. The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited.2. By way of exception 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. However, 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; (b) in the case of the maintenance of plant and machinery already in service within a Member State on 18 June 1994 . 3. The placing on the second-hand market of this substance, preparations containing this substance and plant/machinery containing this substance, shall be prohibited. |
25. Monomethyl-dichloro-diphenyl methaneTrade name: Ugilec 121, Ugilec 21; CAS No — unknown | The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited. |
26. Monomethyl-dibromo-diphenyl methane bromobenzylbromotoluene, mixture of isomersTrade name: DBBT CAS No 99688-47-8 | The placing on the market and use of this substance and of preparations and articles containing it shall be prohibited. |
27. NickelCAS No 7440-02-0 EINECS No 231-111-4 and its compounds | 1. Shall not be used:(a) in all 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:
(c) in articles such as those listed 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 those points.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 Annex I to Directive 67/548/EEC classified as carcinogen category 1 or carcinogen category 2 and labelled at least as ‘Toxic (T)’ with risk phrase R 45: ‘May cause cancer’ or risk phrase R49: ‘May cause cancer by inhalation’, 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 used in substances and preparations placed on the market for sale to the general public in individual concentration equal to or greater than:
|
29. Substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 1 or mutagen category 2 and labelled with risk phrase R46: ‘May cause heritable genetic damage’, and listed as follows:
| Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of dangerous substances and preparations, the packaging of such substances and preparations must be marked legibly and indelibly as follows: ‘Restricted to professional users’ . |
30. Substances which appear in Annex I to Directive 67/548/EEC classified as toxic to reproduction category 1 or toxic to reproduction category 2 and labelled with risk phrase R60: ‘May impair fertility’ and/or R61: ‘May cause harm to the unborn child’, and listed as follows:
| 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 Council Directive 76/768/EEC; (c)
(d) artists' paints covered by Directive 1999/45/EC. |
31.(a) creosote; wash oil CAS No 8001-58-9 EINECS No 232-287-5 (b) creosote oil; wash oil CAS No 61789-28-4 EINECS No 263-047-8 (c) distillates (coal tar), naphthalene oils; naphthalene oil CAS No 84650-04-4 EINECS No 283-484-8 (d) creosote oil, acenaphthene fraction; wash oil CAS No 90640-84-9 EINECS No 292-605-3 (e) distillates (coal tar), upper; heavy anthracene oil CAS No 65996-91-0 EINECS No 266-026-1 (f) anthracene oil CAS No 90640-80-5 EINECS No 292-602-7 (g) tar acids, coal, crude; crude phenols CAS No 65996-85-2 EINECS No 266-019-3 (h) creosote, wood CAS No 8021-39-4 EINECS No 232-419-1 (i) low temperature tar oil, alkaline; extract residues (coal), low temperature coal tar alkaline CAS No 122384-78-5 EINECS No 310-191-5 | 1. Shall not be used as substances or in preparations in the treatment of wood. Furthermore, wood so treated shall not be placed on the market.2. However by way of derogation:(a) relating to the substances and preparations: these 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 0,005 % by mass; (ii) and water extractable phenols at a concentration of less than 3 % by mass. Such substances and preparations 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 dangerous substances and preparations, the packaging of such substances and preparations shall be legibly and indelibly marked as follows: ‘ For use in industrial installations or professional treatment only ’ . (b) relating to wood treated in industrial installations or by professionals according to point (a) which is placed on the market for the first time or retreated in situ : this is permitted for professional and industrial use only, e.g. on railways, in electric power transmission and telecommunications, for fencing, for agricultural purposes (e.g. 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. However, treated wood referred to under paragraph 2(b) and (c) shall not be used:
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32. ChloroformCAS No 67-66-3 EINECS No 200-663-8 33. Carbon tetrachloride-tetrachloromethaneCAS No 56-23-5 EINECS No 200-262-8 34. 1,1,2 TrichloroethaneCAS No 79-00-5 EINECS No 201-166-9 35. 1,1,2,2 TetrachloroethaneCAS No 79-34-5 EINECS No 201-197-8 36. 1,1,1,2 TetrachloroethaneCAS No 630-20-6 37. PentachloroethaneCAS No 76-01-7 EINECS No 200-925-1 38. 1,1 DichloroethyleneCAS No 75-35-4 EINECS No 200-864-0 39. 1,1,1 Trichloroethane, methyl chloroformCAS No 71-55-6 EINECS No 200-756-3 | 1. Shall not be used in concentrations equal to or greater than 0,1 % by weight in substances and preparations placed on the market for sale to the general public and/or in 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 dangerous substances and preparations, the packaging of such substances and preparations containing them in concentrations equal to or greater than 0,1 % shall be legible 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. |
40. Substances meeting the criteria of flammability in Directive 67/548/EEC and classified as flammable, highly flammable or extremely flammable regardless of whether they appear in Annex I to that Directive or not. | 1 Shall not be used on their own or in the form of preparations in aerosol generators that are placed on the market for 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 dangerous substances, the following words must appear legibly and indelibly on the packaging of aerosol generators referred to above:‘For professional users only’ . 3. By way of derogation, paragraphs 1 and 2 shall not apply to the aerosol generators referred to in Article 9a of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers d .4. The articles 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 EINECS No 200-6664 | Shall not be used in the manufacturing or processing of non-ferrous metals. |
42. Alkanes, C 10 -C 13 , chloro (short-chain chlorinated paraffins) (SCCPs)EINECS No 287-476-5 | Shall not be placed on the market for use as substances or as constituents of other substances or preparations in concentrations higher than 1 %:
|
43. Azocolourants | 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 ppm in the finished 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 above 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 for colouring textile and leather articles as a substance or constituent of preparations in concentrations higher than 0,1 % by mass.4. The Commission shall, in the light of new scientific knowledge, review the provisions on azocolourants. |
44. Diphenylether, pentabromo derivative C 12 H 5 Br 5 O | 1. Shall not be placed on the market or used as a substance or as a constituent of preparations in concentrations higher than 0,1 % by mass.2. Articles may not be placed on the market if they, or flame-retarded parts thereof, contain this substance in concentrations higher than 0,1 % by mass. |
45. Diphenylether, octabromo derivative C 12 H 2 Br 8 O | 1. Shall not be placed on the market or used as a substance or as a constituent of substances or of preparations in concentrations higher than 0,1 % by mass.2. Articles may not be placed on the market if they, or flame-retardant parts thereof, contain this substance in concentrations higher than 0,1 % by mass. |
46.(a) Nonylphenol C 6 H 4 (OH)C 9 H 19 (b) Nonylphenol ethoxylate (C 2 H 4 O) n C 15 H 24 O | Shall not be placed on the market or used as a substance or constituent of preparations in concentrations equal or higher than 0,1 % by mass 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:
(6) manufacturing of pulp and paper; (7) cosmetic products; (8) other personal care products except:
(9) co-formulants in pesticides and biocides. |
47. Cement | 1. Cement and cement-containing preparations shall not be used or placed on the market, if they contain, when hydrated, more than 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 dangerous substances and preparations, the packaging of cement or cement-containing preparations shall be 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 preparations are handled solely by machines and in which there is no possibility of contact with the skin. |
48. TolueneCAS No 108-88-3 | Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass in adhesives and spray paints intended for sale to the general public. Member States shall apply these measures from 15 June 2007 . |
49. TrichlorobenzeneCAS No 120-82-1 | Shall not be placed on the market or used as a substance or constituent of preparations in a concentration equal to or higher than 0,1 % by mass for all uses except:
Member States shall apply these measures from 15 June 2007 . |
50. Polycyclic-aromatic hydrocarbons (PAH)1. Benzo(a)pyrene (BaP) CAS No 50-32-8 2. Benzo(e)pyrene (BeP) CAS No 192-97-2 3. Benzo(a)anthracene (BaA) CAS No 56-55-3 4. Chrysen (CHR) CAS No 218-01-9 5. Benzo(b)fluoranthene (BbFA) CAS No 205-99-2 6. Benzo(j)fluoranthene (BjFA) CAS No 205-82-3 7. Benzo(k)fluoranthene (BkFA) CAS No 207-08-9 8. Dibenzo(a, h)anthracene (DBAhA) CAS No 53-70-3 | 1. Extender oils shall not be placed on the market and used for the production of tyres or parts of tyres, if they contain:
These limits are regarded as kept, if the polycyclic aromatics (PCA) extract is less than 3 % by mass, 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, the tyres and treads for retreading manufactured after 1 January 2010 may not be placed on the market if they contain extender oils exceeding the limits indicated in paragraph 1.These limits are 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. Member States shall apply these measures from 1 January 2010 . |
51. The following phthalates (or other CAS- and EINECS numbers covering the substance):
| Shall not be used as substances or as constituents of preparations, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles e . Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material shall not be placed on the market. The Commission shall re-evaluate, by 16 January 2010 , the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. |
52. The following phthalates (or other CAS- and EINECS numbers covering the substance):
| Shall not be used as substances or as constituents of preparations, at concentrations higher than 0,1 % by mass of the plasticised material, in toys and childcare articles e which can be placed in the mouth by children. Toys and childcare articles containing these phthalates in a concentration higher than 0,1 % by mass of the plasticised material shall not be placed on the market. The Commission shall re-evaluate, by 16 January 2010 , the measures provided for in relation to this point in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. |
The name is the same as that used for the substance in Annex I to Directive 67/548/EEC. Whenever possible dangerous substances are designated by their EINECS (European Inventory of Existing Commercial Chemical Substances) or ELINCS (European List of Notified Chemical Substances) names. These are referred to as EC numbers in the table. Other entries not listed in EINECS or ELINCS are designated using an internationally recognised chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases.
The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are listed in the Appendix according to this index number.
For each substance listed in the EINECS there is an identification code. The code starts at 200-001 8.
For each new substance notified under the Directive 67/548/EEC an identification code has been defined and published in the ELINCS. The code starts at 400-010-9.
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 the Foreword of Annex I to Directive 67/548/EEC.
The notes to be taken into account for the purposes of this Regulation are the following:
The name of the substance must appear on the label in the form of one of the designations given in Annex I to Directive 67/548/EEC (see Article 23(2)(a) of that Directive).
In Annex I to Directive 67/548/EEC, use is sometimes made of a general description such as ‘ … compounds ’ or ‘ … salts ’ . In this case, the manufacturer or any other person who places such a substance on the market is required to state on the label the correct name, due account being taken of the Chapter entitled ‘ Nomenclature ’ of the Foreword to that Annex.
Directive 67/548/EEC also requires that the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in Annex I to that Directive (Article 23(2)(c), (d) and (e) of that Directive).
For substances belonging to one particular group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in the appropriate entry in that Annex.
For substances belonging to more than one group of substances included in Annex I to Directive 67/548/EEC, the symbols, indications of danger, R- and S-phrases to be used for each substance shall be those shown in both the appropriate entries given in that Annex. In cases where two different classifications are given in the two entries for the same hazard, the classification reflecting the more severe hazard classification shall be used.
Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.
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 Annex I to Directive 67/548/EEC.
However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer or any person who places such a substance on the market must state on the label the name of the substance followed by the words ‘ non-stabilised ’ .
Substances with specific effects on human health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word ‘ Also ’ .
The classification and label shown for this substance applies to the dangerous property(ies) indicated by the risk phrase(s) in combination with the category(ies) of danger shown. The requirements of Article 6 of Directive 67/548/EEC on manufacturers, distributors, and importers of this substance apply to all other aspects of classification and labelling. The final label shall follow the requirements of section 7 of Annex VI to Directive 67/548/EEC.
This note applies to certain coal- and oil-derived substances and to certain entries for groups of substances in Annex I to Directive 67/548/EEC.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7).
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 (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the S-phrases (2-)9-16 should apply. This note applies to certain complex oil-derived substances in Annex I to Directive 67/548/EC
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.
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 (EINECS No 200-028-5).
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.
The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7).
The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two standard errors, greater than 6μm.
This substance may not require a label according to Article 23 of Directive 67/548/EEC (see section 8 of Annex VI of that Directive).
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 | |
Lead compounds with the exception of those specified elsewhere in this Annex | 082-001-00-6 | A, E | ||
Lead alkyls | 082-002-00-1 | A, 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 | E |
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 |
Substances | Index No | EC No | CAS No | Notes |
---|---|---|---|---|
Linuron (ISO) 3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea | 006-021-00-1 | 206-356-5 | 330-55-2 | E |
6-(2-Chloroethyl)-6(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane; etacelasil | 014-014-00-X | 253-704-7 | 37894-46-5 | |
Flusilazole (ISO); bis(4-fluorophenyl)-(methyl)-(1H-1,2,4-triazol-1-ylmethyl)-silane | 014-017-00-6 | — | 85509-19-9 | E |
A mixture of: 4-[[bis-(4-fluorophenyl)-methylsilyl]methyl]-4H-1,2,4-triazole; 1-[[bis-(4-fluorophenyl)methyl-silyl]methyl]-1H-1,2,4-triazole | 014-019-00-7 | 403-250-2 | — | E |
Potassium dichromate | 024-002-00-6 | 231-906-6 | 7778-50-9 | E |
Ammonium dichromate | 024-003-00-1 | 232-143-1 | 7789-09-5 | E |
Sodium dichromate anhydrate | 024-004-00-7 | 234-190-3 | 10588-01-9 | E |
Sodium dichromate, dihydrate | 024-004-01-4 | 234-190-3 | 7789-12-0 | E |
Sodium chromate | 024-018-00-3 | 231-889-5 | 7775-11-3 | E |
Nickel tetracarbonyl | 028-001-00-1 | 236-669-2 | 13463-39-3 | |
Cadmium fluoride | 048-006-00-2 | 232-222-0 | 7790-79-6 | E |
Cadmium chloride | 048-008-00-3 | 233-296-7 | 10108-64-2 | E |
Cadmium sulphate | 048-009-00-9 | 233-331-6 | 10124-36-4 | E |
Benzo[a]pyrene; benzo[d,e,f]chrysene | 601-032-00-3 | 200-028-5 | 50-32-8 | |
1-Bromopropane Propyl bromide n-Propyl bromide | 602-019-00-5 | 203-445-0 | 106-94-5 | |
1,2,3-Trichloropropane | 602-062-00-X | 202-486-1 | 96-18-4 | D |
Diphenylether; octabromo derivate | 602-094-00-4 | 251-087-9 | 32536-52-0 | |
2-Methoxyethanol; ethylene glycol monomethyl ether; methylglycol | 603-011-00-4 | 203-713-7 | 109-86-4 | |
2-Ethoxyethanol; ethylene glycol monoethyl ether; ethylglycol | 603-012-00-X | 203-804-1 | 110-80-5 | |
1,2-Dimethoxyethane ethylene glycol dimethyl ether EGDME | 603-031-00-3 | 203-794-9 | 110-71-4 | |
2,3-Epoxypropan-1-ol; glycidol oxiranemethanol | 603-063-00-8 | 209-128-3 | 556-52-5 | E |
2-Methoxypropanol | 603-106-00-0 | 216-455-5 | 1589-47-5 | |
Bis(2-methoxyethyl) ether | 603-139-00-0 | 203-924-4 | 111-96-6 | |
R-2,3-epoxy-1-propanol | 603-143-002 | 404-660-4 | 57044-25-4 | E |
1,2-Bis(2-methoxyethoxy)ethane TEGDME; Triethylene glycol dimethyl ether; Triglyme | 603-176-00-2 | 203-977-3 | 112-49-2 | |
4,4'-isobutylethylidenediphenol; 2,2-bis (4'-hydroxyphenyl)-4-methylpentane | 604-024-00-8 | 401-720-1 | 6807-17-6 | |
Tetrahydrothiopyran-3-carboxaldehyde | 606-062-00-0 | 407-330-8 | 61571-06-0 | |
2-Methoxyethyl acetate; ethylene glycol monomethyl ether acetate; methylglycol acetate | 607-036-00-1 | 203-772-9 | 110-49-6 | |
2-Ethoxyethyl acetate; ethylene glycol monoethyl ether acetate; ethylglycol acetate | 607-037-00-7 | 203-839-2 | 111-15-9 | |
2-Ethylhexyl 3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl methyl thio acetate | 607-203-00-9 | 279-452-8 | 80387-97-9 | |
Bis(2-Methoxyethyl) phthalate | 607-228-00-5 | 204-212-6 | 117-82-8 | |
2-Methoxypropyl acetate | 607-251-00-0 | 274-724-2 | 70657-70-4 | |
Fluazifop-butyl (ISO); butyl (RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate | 607-304-00-8 | 274-125-6 | 69806-50-4 | |
Vinclozolin (ISO); N-3,5-Dichlorophenyl-5-methyl-5-vinyl-1,3-oxazolidine-2,4-dione | 607-307-00-4 | 256-599-6 | 50471-44-8 | |
Methoxyacetic acid | 607-312-00-1 | 210-894-6 | 625-45-6 | E |
Bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP | 607-317-00-9 | 204-211-0 | 117-81-7 | |
Dibutyl phthalate; DBP | 607-318-00-4 | 201-557-4 | 84-74-2 | |
(+/-) tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate | 607-373-00-4 | 414-200-4 | 119738-06-6 | E |
1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1] n-pentyl-isopentylphthalate [2] di-n-pentyl phthalate [3] Diisopentylphthalate [4] | 607-426-00-1 | 284-032-2 [1]-[2] 205-017-9 [3]-[4] | 84777-06-0 [1]-[2] 131-18-0 [3] 42925-80-4 [4] | |
Benzyl butyl phthalate BBP | 607-430-00-3 | 201-622-7 | 85-68-7 | |
1,2-Benzenedicarboxylic acid di-C7-11-branched and linear alkylesters | 607-480-00-6 | 271-084-6 | 68515-42-4 | |
A mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate; trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate | 607-487-00-4 | 402-660-9 | — | |
Dinocap (ISO) | 609-023-00-6 | 254-408-0 | 39300-45-3 | E |
Binapacryl (ISO); 2-sec-butyl-4,6-dinitrophenyl-3-methylcrotonate | 609-024-00-1 | 207-612-9 | 485-31-4 | |
Dinoseb; 6-sec-butyl-2,4-dinitrophenol | 609-025-00-7 | 201-861-7 | 88-85-7 | |
Salts and esters of dinoseb, with the exception of those specified elsewhere in this Annex | 609-026-00-2 | |||
Dinoterb; 2-tert-butyl-4,6-dinitrophenol | 609-030-00-4 | 215-813-8 | 1420-07-1 | |
Salts and esters of dinoterb | 609-031-00-X | |||
Nitrofen (ISO); 2,4 dichlorophenyl 4-nitrophenyl ether | 609-040-00-9 | 217-406-0 | 1836-75-5 | |
Methyl-ONN-azoxymethyl acetate; methyl azoxy methyl acetate | 611-004-00-2 | 209-765-7 | 592-62-1 | |
2-[2-hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one | 611-131-00-3 | 420-580-2 | — | |
Azafenidin | 611-140-00-2 | — | 68049-83-2 | |
Tridemorph (ISO); 2,6-dimethyl-4-tridecylmorpholine | 613-020-00-5 | 246-347-3 | 24602-86-6 | |
Ethylene thiourea; imidazolidine-2-thione; 2-imidazoline-2-thiol | 613-039-00-9 | 202-506-9 | 96-45-7 | |
Carbendazim (ISO) methyl benzimidazol-2-ylcarbamate | 613-048-00-8 | 234-232-0 | 10605-21-7 | |
Benomyl (ISO) methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate | 613-049-00-3 | 241-775-7 | 17804-35-2 | |
Cycloheximide | 613-140-00-8 | 200-636-0 | 66-81-9 | |
Flumioxazin (ISO); N-(7-Fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboxamide | 613-166-00-X | — | 103361-09-7 | |
(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)-methyl]oxirane | 613-175-00-9 | 406-850-2 | 106325-08-0 | |
3-Ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine | 613-191-00-6 | 421-150-7 | 143860-04-2 | |
A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione; a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione | 613-199-00-X | 421-550-1 | — | |
N, N-dimethylformamide; dimethyl formamide | 616-001-00-X | 200-679-5 | 68-12-2 | |
N, N-Dimethylacetamide | 616-011-00-4 | 204-826-4 | 127-19-5 | E |
Formamide | 616-052-00-8 | 200-842-0 | 75-12-7 | |
N-methylacetamide | 616-053-00-3 | 201-182-6 | 79-16-3 | |
N-methylformamide | 616-056-00-X | 204-624-6 | 123-39-7 | E |
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-) |
a ESO: European standardisation organisations:
| |||
European standardisation organisation a | Reference and title of the standard | Reference document | Reference of the superseded standard |
---|---|---|---|
CEN | Leather — Chemical tests — Determination of certain azocolorants in dyed leathers | CEN ISO/TS 17234:2003 | NONE |
CEN | Textiles — Methods for the determination of certain aromatic amines derived from azocolorants — Part 1: Detection of the use of certain azo colorants accessible without extraction | EN 14362-1:2003 | NONE |
CEN | Textiles — Methods for determination of certain aromatic amines derived from azocolorants — Part 2: Detection of the use of certain azo colorants accessible by extracting the fibres | EN 14362-2:2003 | NONE |
[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.]
[X1Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the safety data sheet of the chemical identity of a substance which is exclusively classified as irritant with the exception of those assigned R41 or irritant in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC, or harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC presenting acute lethal effects alone, will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Part B of Annex VI to Directive 1999/45/EC, refer to that substance either by means of a name that identifies the most important functional chemical groups, or by means of an alternative name.]
[X1 OJ L 399, 30.12.1989, p. 18 . Directive as last amended by Regulation (EC) No 1882/2003.]
[X1 OJ L 100, 19.4.1994, p. 1 . Directive as amended by Regulation (EC) No 1882/2003.]
[X1This information cannot be given for the preparation because it is substance specific. It should therefore be given, where available and appropriate, for each constituent substance in the preparation which is required to be listed in the Safety Data Sheet according to the rules under Section 3 of this Annex.]
[X1 OJ L 319, 12.12.1994, p. 7 . Directive as last amended by Commission Directive 2004/111/EC ( OJ L 365, 10.12.2004, p. 25 ).]
[X1 OJ L 235, 17.9.1996, p. 25 . Directive as last amended by Commission Directive 2004/110/EC ( OJ L 365, 10.12.2004, p. 24 ).]
[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.]
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).
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