Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilDangos y teitl llawn

1. PART 1: INTRODUCTION TO THE LIST OF [F1 MANDATORY] CLASSIFICATIONS AND LABELLING U.K.

1.1. Information listed for each entry U.K.

1.1.1. Numbering of entries and identification of a substance U.K.

1.1.1.1. Index numbers U.K.

Entries in [F2 the GB mandatory classification and labelling list] are listed according to the atomic number of the element most characteristic of the properties of the substance. Organic substances, because of their variety, have been placed in classes. The Index number for each substance is in the form of a digit sequence of the type ABC-RST-VW-Y. ABC corresponds to the atomic number of the most characteristic element or the most characteristic organic group in the molecule. RST is the consecutive number of the substance in the series ABC. VW denotes the form in which the substance is produced or placed on the market. Y is the check-digit calculated in accordance with the 10-digit ISBN method. This number is indicated in the column entitled ‘Index No’.

Textual Amendments

F2 Words in Annex 6 point 1.1.1.1 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(b) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c));2020 c. 1, Sch. 5 para. 1(1)

1.1.1.2. EC numbers U.K.

The EC number, i.e. EINECS, ELINCS or NLP, is the official number of the substance within the European Union. The EINECS number can be obtained from the European Inventory of Existing Commercial Chemical Substance (EINECS)(1). The ELINCS number can be obtained from the European List of Notified Substances (as amended) (EUR 22543 EN, Office for Official Publications of the European Communities, 2006, ISSN 1018-5593). The NLP number can be obtained from the list of ‘No-longer-polymers’ (as amended) (Document, Office for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0). The EC number is a seven-digit system of the type XXX-XXX-X which starts at 200-001-8 (EINECS), at 400-010-9 (ELINCS) and at 500-001-0 (NLP). This number is indicated in the column entitled ‘EC No’.

1.1.1.3. CAS number U.K.

The Chemical Abstracts Service (CAS) number is also included to assist identification of the entry. It should be noted that the EINECS number includes both anhydrous and hydrated forms of a substance, and there are frequently different CAS numbers for anhydrous and hydrated forms. The CAS number included is for the anhydrous form only, and therefore the CAS number shown does not always describe the entry as accurately as the EINECS number. This number is indicated in the column entitled ‘CAS No’.

1.1.1.4. [F3 Chemical name] U.K.

Wherever possible, hazardous substances are designated by their IUPAC names. Substances listed in EINECS, ELINCS or the list of ‘No-longer-polymers’ are designated using the names in these lists. Other names, such as usual or common names, are included in some cases. Whenever possible, plant protection products and biocides are designated by their ISO names.

Impurities, additives and minor components are normally not mentioned unless they contribute significantly to the classification of the substance.

Some substances are described with a specific percentage of purity. Substances containing a higher content of active material (e.g. organic peroxide) than this percentage are not included in the entry in Part 3 and may have other hazardous properties (e.g. explosive) and should be classified and labelled accordingly.

Where specific concentration limits are shown, these apply to the substance or substances shown in the entry. In particular, in the case of entries which are mixtures of substances or substances described with a specific percentage of purity, the limits apply to the substance as described in Part 3 and not the pure substance.

Without prejudice to Article 17(2), for substances appearing in [F4 the GB mandatory classification and labelling list], the name of the substance to be used on the label shall be one of the designations given there. For certain substances, additional information has been added in square brackets in order to help identify the substance. This additional information need not be included on the label.

Textual Amendments

F4 Words in Annex 6 point 1.1.1.4 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(c) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

Certain entries contain a reference to impurities; in these cases the name of the substance is followed by the text: ‘(containing ≥ xx % impurity)’. The reference in brackets is then to be considered as a part of the name, and must be included on the label.

Textual Amendments

F3 Substituted by Commission Regulation (EU) 2018/1480 of 4 October 2018 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting Commission Regulation (EU) 2017/776 (Text with EEA relevance).

1.1.1.5. Entries for groups of substances U.K.

A number of group entries are included in [F5 the GB mandatory classification and labelling list]. In these cases, the classification and labelling requirements will apply to all substances covered by the description.

Textual Amendments

F5 Words in Annex 6 point 1.1.1.5 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(d) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

In some cases, there are classification and labelling requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in [F5 the GB mandatory classification and labelling list] for the substance and the group entry will be annotated with the phrase ‘except those specified elsewhere in [F5 the list]’.

In some cases, individual substances may be covered by more than one group entry. In these cases, the classification of the substance reflects the classification for each of the two group entries. In cases where different classifications for the same hazard are given, the most severe classification shall be applied.

Entries in [F5 the GB mandatory classification and labelling list] for salts (under any denomination) cover both anhydrous and hydrous forms, unless specified otherwise.

EC or CAS numbers are not usually included for entries which comprise more than four individual substances.

[F6 1.1.2. Information related to the classification and labelling of each entry in [F7 the GB mandatory classification and labelling list]] U.K.

1.1.2.1. Classification codes U.K.

1.1.2.1.1. Hazard class and category codes U.K.

The classification for each entry is based on the criteria set out in Annex I, in accordance with Article 13(a) and is presented in the form of a code representing the hazard class and the category or categories/divisions/types within this hazard class.

The Hazard class and category codes used for each of the hazard categories/divisions/types included in a class are shown in Table 1.1.

Table 1.1

a see Note U in 1.1.3.
Hazard Class	Hazard Class and Category Code
Explosive	Unst. Expl. Expl. 1.1 Expl. 1.2 Expl. 1.3 Expl. 1.4 Expl. 1.5 Expl. 1.6
[F8 Flammable gases	Flam. Gas 1A Flam. Gas 1B Flam. Gas 2 Pyr. Gas Chem. Unst. Gas A Chem. Unst. Gas B]
[F9 Aerosol	Aerosol 1 Aerosol 2 Aerosol 3]
Oxidising gas	Ox. Gas 1
Gases under pressure	Press. Gasa
Flammable liquid	Flam. Liq. 1 Flam. Liq. 2 Flam. Liq. 3
Flammable solid	Flam. Sol. 1 Flam. Sol. 2
Self-reactive substance or mixture	Self-react. A Self-react. B Self-react. CD Self-react. EF Self-react. G
Pyrophoric liquid	Pyr. Liq. 1
Pyrophoric solid	Pyr. Sol. 1
Self-heating substance or mixture	Self-heat. 1 Self-heat. 2
Substance or mixture which in contact with water emits flammable gas	Water-react. 1 Water-react. 2 Water-react. 3
Oxidising liquid	Ox. Liq. 1 Ox. Liq. 2 Ox. Liq. 3
Oxidising solid	Ox. Sol. 1 Ox. Sol. 2 Ox. Sol. 3
Organic peroxide	Org. Perox. A Org. Perox. B Org. Perox. CD Org. Perox. EF Org. Perox. G
Substance or mixture corrosive to metals	Met. Corr. 1
[F10 Desensitised explosives	Desen. Expl. 1 Desen. Expl. 2 Desen. Expl. 3 Desen. Expl. 4]
Acute toxicity	Acute Tox. 1 Acute Tox. 2 Acute Tox. 3 Acute Tox. 4
[F11 Skin corrosion/irritation	Skin Corr. 1 Skin Corr. 1A Skin Corr. 1B Skin Corr. 1C Skin Irrit. 2]
Serious eye damage/eye irritation	Eye Dam. 1 Eye Irrit. 2
Respiratory/skin sensitization	[F12 Resp. Sens. 1, 1A, 1B] [F12 Skin. Sens. 1, 1A, 1B]
Germ cell mutagenicity	Muta. 1A Muta. 1B Muta. 2
Carcinogenicity	Carc. 1A Carc. 1B Carc. 2
Reproductive toxicity	Repr. 1A Repr. 1B Repr. 2 Lact.
Specific target organ toxicity — single exposure	STOT SE 1 STOT SE 2 STOT SE 3
Specific target organ toxicity — repeated exposure	STOT RE 1 STOT RE 2
Aspiration hazard	Asp. Tox. 1
Hazardous to the aquatic environment	Aquatic Acute 1 Aquatic Chronic 1 Aquatic Chronic 2 Aquatic Chronic 3 Aquatic Chronic 4
Hazardous for the ozone layer	[F12 Ozone 1]

Textual Amendments

F8 Substituted by Commission Regulation (EU) 2019/521 of 27 March 2019 amending, for the purposes of its adaptation to technical and scientific progress Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F9 Substituted by Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F10 Inserted by Commission Regulation (EU) 2019/521 of 27 March 2019 amending, for the purposes of its adaptation to technical and scientific progress Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F11 Substituted by Commission Regulation (EU) 2016/918 of 19 May 2016 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F12 Substituted by Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

1.1.2.1.2. Hazard statement codes U.K.

[F9 The hazard statements assigned in accordance with Article 13(b) are indicated in accordance with Annex III. In addition, for certain hazard statements, letters are added to the 3-digit hazard statement code for further differentiations. The following additional codes are used:]

H350i	May cause cancer by inhalation.
H360F	May damage fertility.
H360D	May damage the unborn child.
H361f	Suspected of damaging fertility.
H361d	Suspected of damaging the unborn child.
H360FD	May damage fertility. May damage the unborn child.
H361fd	Suspected of damaging fertility. Suspected of damaging the unborn child.
H360Fd	May damage fertility. Suspected of damaging the unborn child.
H360Df	May damage the unborn child. Suspected of damaging fertility.

1.1.2.2. Labelling codes U.K.

In the labelling column, the following elements are listed:

(i)

the hazard pictogram codes as specified in Annex V, in accordance with the precedence rules in Article 26;

(ii)

the signal word code ‘Dgr’ for ‘Danger’or ‘Wng’ for ‘Warning’, in accordance with the precedence rule in Article 20(3);

(iii)

the hazard statement codes as specified in Annex III, in accordance with the classification;

(iv)

the codes for the supplemental statements assigned in accordance with Article 25(1) and the rules specified in Annex II, part 1.

[F6 1.1.2.3. Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE) U.K.

Specific concentration limits (SCL), where different from the generic concentration limits given in Annex I for a certain category, are given in a separate column together with the classification concerned using the same codes as under 1.1.2.1.1. Also harmonised ATEs are listed in the same column of [F13 the GB mandatory classification and labelling list]. The SCLs and harmonised ATEs must be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance. When applying an ATE, the additivity formula as described in 3.1.3.6 of Annex I shall be used. Where no specific concentration limits are given [F13 in the list] for a certain category, the generic concentration limits given in Annex I must be applied for the classification of substances containing impurities, additives or individual constituents or for mixtures. If harmonised ATE values are missing for acute toxicity the correct value has to be established by using the available data.

Textual Amendments

F13 Words in Annex 6 point 1.1.2.3 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(f) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the mixture.

In case an M-factor has been harmonised for substances classified as hazardous to the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, that M-factor is given in [F13 the GB mandatory classification and labelling list] in the same column as the specific concentration limits. In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation. Where a single M-factor is given in [F13 the GB mandatory classification and labelling list] and the substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, that M-factor shall be used by the manufacturer, importer or downstream user for the classification of a mixture containing this substance for acute and long-term aquatic hazards using the summation method. Where no M-factor is given in [F13 the GB mandatory classification and labelling list], M-factor(s) based on available data for the substance shall be set by the manufacturer, importer or downstream user. For the setting and use of M-factors, see Section 4.1.3.5.5.5 of Annex I.]

Textual Amendments

F6 Substituted by Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F7 Words in Annex 6 point 1.1.2 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(e) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

1.1.3. Notes assigned to an entry U.K.

The note(s) assigned to an entry are listed in the column entitled ‘Notes’. The meaning of the notes is as follows:

1.1.3.1. Notes relating to the identification, classification and labelling of substances U.K.

Note A: U.K.

Without prejudice to Article 17(2), the name of the substance must appear on the label in the form of one of the designations given in [F14 the GB mandatory classification and labelling list].

Textual Amendments

F14 Words in Annex 6 point 1.1.3.1 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(g)(i) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

In [F14 the GB mandatory classification and labelling list], use is sometimes made of a general description such as ‘... compounds’ or ‘... salts’. In this case, the supplier is required to state on the label the correct name, due account being taken of section 1.1.1.4.

Note B: U.K.

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and, therefore, these solutions require different classification and labelling since the hazards vary at different concentrations.

In [F14 the GB mandatory classification and labelling list] entries with Note B have a general designation of the following type: ‘nitric acid … %’.

In this case the supplier must state the percentage concentration of the solution on the label. Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.

Note C: U.K.

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

In this case the supplier must state on the label whether the substance is a specific isomer or a mixture of isomers.

Note D: U.K.

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 [F14 the GB mandatory classification and labelling list].

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier must state on the label the name of the substance followed by the words ‘non-stabilised’.

F15 Note E (Table 3.2): U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F15 Deleted by Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

Note F: U.K.

This substance may contain a stabiliser. If the stabiliser changes the hazardous properties of the substance, as indicated by the classification in [F14 the GB mandatory classification and labelling list], classification and labelling should be provided in accordance with the rules for classification and labelling of hazardous mixtures.

Note G: U.K.

This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods. The classification and labelling provided shall reflect the explosive properties.

F16 Note H (Table 3.1): U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F16 Deleted by Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

F16 Note H (Table 3.2): U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Note J: U.K.

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (EINECS No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in [F14 the GB mandatory classification and labelling list].

[F6 Note K: U.K.

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in [F17 the GB mandatory classification and labelling list].]

Textual Amendments

F17 Words in Annex 6 point 1.1.3.1 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(g)(ii) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

Note L: U.K.

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 ‘Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions — Dimethyl sulphoxide extraction refractive index method’, Institute of Petroleum, London. This note applies only to certain complex oil-derived substances in [F17 the GB mandatory classification and labelling list].

Note M: U.K.

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). This note applies only to certain complex coal-derived substances in [F17 the GB mandatory classification and labelling list].

Note N: U.K.

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. This note applies only to certain complex oil-derived substances in [F17 the GB mandatory classification and labelling list].

[F6 Note P: U.K.

The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7).

When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply.

This note applies only to certain complex oil-derived substances in [F18 the GB mandatory classification and labelling list].]

Textual Amendments

F18 Words in Annex 6 point 1.1.3.1 substituted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(g)(iv) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

Note Q: U.K.

The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions:

• a short term biopersistence test by inhalation has shown that the fibres longer than 20 μm have a weighted half-life less than 10 days; or

• a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 μm have a weighted half-life less than 40 days; or

• an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity; or

• absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.

Note R: U.K.

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 6 μm.

[F6 Note S: U.K.

This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) F19 ....]

Textual Amendments

F19 Words in Annex VI omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(g)(v); 2020 c. 1, Sch. 5 para. 1(1), (it is provided that (31.12.2020) words "Table 3.1" omitted)

Note T: U.K.

This substance may be marketed in a form which does not have the physical hazards as indicated by the classification in the entry in Part 3. If the results of the relevant method or methods in accordance with Part 2 of Annex I of this Regulation show that the specific form of substance marketed does not exhibit this physical property or these physical hazards, the substance shall be classified in accordance with the result or results of this test or these tests. Relevant information, including reference to the relevant test method(s) shall be included in the safety data sheet.

[F11 [F6 Note U (Table 3):] U.K.

When put on the market gases have to be classified as ‘ Gases under pressure ’ , in one of the groups compressed gas, liquefied gas, refrigerated liquefied gas or dissolved gas. The group depends on the physical state in which the gas is packaged and therefore has to be assigned case by case. The following codes are assigned:

• Press. Gas (Comp.)

• Press. Gas (Liq.)

• Press. Gas (Ref. Liq.)

• Press. Gas (Diss.)

Aerosols shall not be classified as gases under pressure (See Annex I, Part 2, Section 2.3.2.1, Note 2).]

1.1.3.2. Notes relating to the classification and labelling of mixtures U.K.

[F6 Note 1: U.K.

The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.]

Note 2: U.K.

The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.

Note 3: U.K.

The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture.

Note 5: U.K.

The concentration limits for gaseous mixtures are expressed as volume per volume percentage.

Note 7: U.K.

Alloys containing nickel are classified for skin sensitisation when the release rate of 0,5 μg Ni/cm²/week, as measured by the European Standard reference test method EN 1811, is exceeded.

[F20 Note 8: U.K.

The classification as a carcinogen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0,1 %.]

Textual Amendments

F20 Inserted by Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

[F20 Note 9: U.K.

The classification as a mutagen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1 %.]

F15 1.1.4. Information related to the classification and labelling of each entry in Table 3.2 U.K.

F15 1.1.4.1. Classification codes U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15 1.1.4.2. Labelling codes U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15 1.1.4.3. Specific Concentration Limits U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15 1.1.4.4. Non-conformity with Table 3.1 for physical hazards U.K.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F6 1.2. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC] U.K.

[F6 1.2.1. Minimum classification U.K.

For certain hazard classes, including acute toxicity and STOT repeated exposure, the classification according to the criteria in Directive 67/548/EEC does not correspond directly to the classification in a hazard class and category under this Regulation. In these cases the classification in [F21 the GB mandatory classification and labelling list] shall be considered as a minimum classification. This classification shall be applied if none of the following conditions are fulfilled:

Textual Amendments

F21 Words in Annex 6 point 1.2.1 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(h) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

• the manufacturer or importer has access to data or other information, as specified in Part 1 of Annex I, that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied,

• the minimum classification can be further refined based on the translation table in Annex VII when the physical state of the substance used in the acute inhalation toxicity test is known to the manufacturer or importer. The classification as obtained from Annex VII shall then substitute the minimum classification indicated in [F21 the GB mandatory classification and labelling list] if it differs from it.

Minimum classification for a category is indicated by the reference * in the column ‘ Classification ’ in [F21 the GB mandatory classification and labelling list].

The reference * can also be found in the column ‘ Specific Conc. Limits and M-factors and Acute Toxicity Estimates (ATE) ’ where it indicates that the entry concerned had specific concentration limits under Directive 67/548/EEC for acute toxicity. These concentration limits cannot be ‘ translated ’ into concentration limits under this Regulation, especially when a minimum classification is given. However, when the reference * is shown, the classification for acute toxicity for this entry may be of special concern.]

[F6 1.2.2. Route of exposure cannot be excluded U.K.

For certain hazard classes, e.g. STOT, the route of exposure should be indicated in the hazard statement only if it is conclusively proven that no other route of exposure can cause the hazard in accordance to the criteria in Annex I. Under Directive 67/548/EEC the route of exposure was indicated for classifications with R48 when there was data justifying the classification for this route of exposure. The classification under 67/548/EEC indicating the route of exposure has been translated into the corresponding class and category according to this Regulation, but with a general hazard statement not specifying the route of exposure as the necessary information is not available.

These hazard statements are indicated by the reference ** [F22 in the GB mandatory classification and labelling list].]

Textual Amendments

F22 Words in Annex 6 point 1.2.2 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(i) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

[F6 1.2.3. Hazard statements for reproductive toxicity U.K.

Hazard statements H360 and H361 indicate a general concern for effects on fertility and/or development: ‘ May damage/Suspected of damaging fertility or the unborn child ’ . According to the criteria, the general hazard statement can be replaced by the hazard statement indicating the specific effect of concern in accordance with Section 1.1.2.1.2. When the other differentiation is not mentioned, this is due to evidence proving no such effect, inconclusive data or no data and the obligations in Article 4(3) shall apply for that differentiation.

In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive.

These hazard statements are indicated by the reference *** [F23 in the GB mandatory classification and labelling list].]

Textual Amendments

F23 Words in Annex 6 point 1.2.3 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(j) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

[F6 1.2.4. Correct classification for physical hazards could not be established U.K.

For some entries the correct classification for physical hazards could not be established because sufficient data are not available for the application of the classification criteria in this Regulation. The entry might be assigned to a different (also higher) category or even another hazard class than indicated. The correct classification shall be confirmed by testing.

The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** [F24 in the GB mandatory classification and labelling list].]

Textual Amendments

F24 Words in Annex 6 point 1.2.4 substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(k) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(c)); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F1 Word in Annex Pt. 1 title substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 57(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ C 146A, 15.6.1990.