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) (c. 1272)

ANNEX II U.K. SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES

This Annex consists of 5 parts:

• Part 1 contains special rules for the labelling of certain classified substances and mixtures.

• Part 2 sets out rules for additional hazard statements to be included on the label of certain mixtures.

• Part 3 sets out special rules for packaging.

• Part 4 sets out a special rule for the labelling of plant protection products.

• Part 5 sets up a list of hazardous substances and mixtures to which Article 29(3) applies.

1. PART 1: SUPPLEMENTAL HAZARD INFORMATION U.K.

The statements set out in sections 1.1 and 1.2 shall be assigned in accordance with Article 25(1) to substances and mixtures classified for physical, health or environmental hazards.

1.1. Physical properties U.K.

F1 1.1.1. EUH001 — ‘Explosive when dry’ U.K.

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

Textual Amendments

F1 Deleted 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).

F2 1.1.2. EUH006 — ‘Explosive with or without contact with air’ U.K.

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

Textual Amendments

F2 Deleted 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).

[F3 1.1.1.] EUH014 — ‘Reacts violently with water’ U.K.

For substances and mixtures which react violently with water, such as acetyl chloride, alkali metals, titanium tetrachloride.

Textual Amendments

F3 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).

[F3 1.1.2.] EUH018 — ‘In use, may form flammable/explosive vapour-air mixture’ U.K.

For substances and mixtures not classified as flammable themselves, which may form flammable/explosive vapour-air mixtures. For substances this might be the case for halogenated hydrocarbons and for mixtures this might be the case due to a volatile flammable component or due to the loss of a volatile non-flammable component.

[F3 1.1.3.] EUH019 — ‘May form explosive peroxides’ U.K.

For substances and mixtures which may form explosive peroxides during storage, such as diethyl ether, 1,4-dioxane.

[F3 1.1.4.] EUH044 — ‘Risk of explosion if heated under confinement’ U.K.

For substances and mixtures not in themselves classified as explosive in accordance with section 2.1 of Annex I, but which may nevertheless display explosive properties in practice if heated under sufficient confinement. In particular, substances which decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers.

1.2. Health properties U.K.

1.2.1. EUH029 — ‘Contact with water liberates toxic gas’ U.K.

For substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorus pentasulphide.

1.2.2. EUH031 — ‘Contact with acids liberates toxic gas’ U.K.

For substances and mixtures which react with acids to evolve gases classified for acute toxicity in category 3 in dangerous amounts, such as sodium hypochlorite, barium polysulphide.

1.2.3. EUH032 — ‘Contact with acids liberates very toxic gas’ U.K.

For substances and mixtures which react with acids to evolve gases classified for acute toxicity in category 1 or 2 in dangerous amounts, such as salts of hydrogen cyanide, sodium azide.

1.2.4. EUH066 — ‘Repeated exposure may cause skin dryness or cracking’ U.K.

For substances and mixtures which may cause concern as a result of skin dryness, flaking or cracking but which do not meet the criteria for skin irritancy in section 3.2 of Annex I, based on either:

• practical observations; or

• relevant evidence concerning their predicted effects on the skin.

1.2.5. EUH070 — ‘Toxic by eye contact’ U.K.

For substances or mixtures where an eye irritation test has resulted in overt signs of systemic toxicity or mortality among the animals tested, which is likely to be attributed to absorption of the substance or mixture through the mucous membranes of the eye. The statement shall also be applied if there is evidence in humans for systemic toxicity after eye contact.

The statement shall also be applied where a substance or a mixture contains another substance labelled for this effect, if the concentration of this substance is equal to, or greater than 0,1 %, unless otherwise specified in [F4 the GB mandatory classification and labelling list].

Textual Amendments

F4 Words in Annex 2 point 1.2.5 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. 56(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 17(b)); 2020 c. 1, Sch. 5 para. 1(1)

1.2.6. EUH071 — ‘Corrosive to the respiratory tract’ U.K.

For substances and mixtures in addition to classification for inhalation toxicity, if data are available that indicate that the mechanism of toxicity is corrosivity, in accordance with section 3.1.2.3.3 and Note 1 of Table 3.1.3 in Annex I.

For substances and mixtures in addition to classification for skin corrosivity, if no acute inhalation test data are available and which may be inhaled.

2. PART 2: SPECIAL RULES FOR SUPPLEMENTAL LABEL ELEMENTS FOR CERTAIN MIXTURES U.K.

The statements set out in sections 2.1 to 2.10 shall be assigned to mixtures in accordance with Article 25(6).

2.1. Mixtures containing lead U.K.

The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the mixture, as determined in accordance with ISO standard 6503, shall bear the following statement:

EUH201 — ‘Contains lead. Should not be used on surfaces liable to be chewed or sucked by children’

In the case of packages the contents of which are less than 125 ml, the statement may be as follows:

EUH201A — ‘Warning! Contains lead’

2.2. Mixtures containing cyanoacrylates U.K.

The label on the immediate packaging of adhesives based on cyanoacrylate shall bear the following statement:

EUH202 — ‘Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of the reach of children’

Appropriate advice on safety shall accompany the package.

2.3. Cements and cement mixtures U.K.

Unless cements or cement mixtures are already classified and labelled as a sensitiser with the hazard statement H317, ‘May cause an allergic skin reaction’, the label on the packaging of cements and cement mixtures that contain, when they are hydrated, more than 0,0002 % soluble chromium (VI) of the total dry weight of the cement shall bear the statement:

EUH203 — ‘Contains chromium (VI). May produce an allergic reaction’

If reducing agents are used, then the packaging of cement or cement-containing mixtures shall include information on the packing date, 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 0,0002 %.

2.4. Mixtures containing isocyanates U.K.

Unless already identified on the label of the packaging, mixtures containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) shall bear the following statement:

EUH204 — ‘Contains isocyanates. May produce an allergic reaction.’

2.5. Mixtures containing epoxy constituents with an average molecular weight ≤ 700 U.K.

Unless already identified on the label of the packaging, mixtures containing epoxy constituents with an average molecular weight ≤ 700 shall bear the following statement:

EUH205 — ‘Contains epoxy constituents. May produce an allergic reaction.’

2.6. Mixtures sold to the general public which contain active chlorine U.K.

The label on the packaging of mixtures containing more than 1 % of active chlorine shall bear the following statement:

EUH206 — ‘Warning! Do not use together with other products. May release dangerous gases (chlorine)’

2.7. Mixtures containing cadmium (alloys) and intended to be used for brazing or soldering U.K.

The label on the packaging of the above mentioned mixtures shall bear the following statement:

EUH207 — ‘Warning! Contains cadmium. Dangerous fumes are formed during use. See information supplied by the manufacturer. Comply with the safety instructions’

[F5 2.8. Mixtures containing at least one sensitising substance U.K.

The label on the packaging of mixtures not classified as sensitising but containing at least one substance classified as sensitising and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the statement:

EUH208 — ‘ Contains (name of sensitising substance). May produce an allergic reaction ’ .

Mixtures classified as sensitising containing other substance(s) classified as sensitising (in addition to the one that leads to the classification of the mixture) and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I shall bear the name(s) of that/those substance(s) on the label.

[F6 Where a mixture is labelled in accordance with Section 2.4 or 2.5, the statement EUH208 may be omitted from the label for the substance concerned.]]

Textual Amendments

F6 Inserted 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).

Textual Amendments

F5 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).

2.9. Liquid mixtures containing halogenated hydrocarbons U.K.

For liquid mixtures which show no flashpoint or a flashpoint higher than 60 ^oC but not more than 93 ^oC and contain a halogenated hydrocarbon and more than 5 % highly flammable or flammable substances, the label on the packaging shall bear one of the following statements, depending on whether the substances referred to above are highly flammable or flammable:

EUH209 — ‘Can become highly flammable in use’ or

EUH209A — ‘Can become flammable in use’

2.10. Mixtures not intended for the general public U.K.

For mixtures not classified as hazardous but which contain:

• [F5 ≥ 0,1 % of a substance classified as skin sensitiser category 1, 1B, respiratory sensitiser category 1, 1B, or carcinogenic category 2, or

• ≥ 0,01 % of a substance classified as skin sensitiser category 1A, respiratory sensitiser category 1A, or]

• [F3 ≥ one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit, or]

• ≥ 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, or with effects on or via lactation; or

• at least one substance in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures either:

  • classified with other health or environmental hazards; or

  • for which there are F7 ... workplace exposure limits

Textual Amendments

F7 Word in Annex 2 point 2.10 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. 56(b); 2020 c. 1, Sch. 5 para. 1(1)

the label on the packaging shall bear the statement:

EUH210 — ‘Safety data sheet available on request’.

2.11 Aerosols U.K.

Note that aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 in the Annex to Directive 75/324/EEC.

3. PART 3: SPECIAL RULES ON PACKAGING U.K.

3.1. Provisions relating to child-resistant fastenings U.K.

3.1.1. Packaging to be fitted with child-resistant fastenings U.K.

3.1.1.1. Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1 shall be fitted with child-resistant fastenings. U.K.

3.1.1.2. Packaging of whatever capacity containing a substance or mixture supplied to the general public presenting an aspiration hazard and classified according to sections 3.10.2 and 3.10.3 of Annex I and labelled according to section 3.10.4.1 of Annex I, with the exception of substances and mixtures placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment, shall be fitted with child-resistant fastenings. U.K.

3.1.1.3 Where a substances or mixture has at least one of the substances mentioned below present in a concentration equal to or greater than the maximum individual concentrations specified, which are supplied to the general public, the packaging of whatever capacity shall be fitted with child-resistant fastenings. U.K.

No	Identification of the substance			Concentration limit
	CAS No	Name	EC No
1	67-56-1	methanol	200-659-6	≥ 3 %
2	75-09-2	dichloromethane	200-838-9	≥ 1 %

3.1.2 Reclosable packages U.K.

Child-resistant fastenings used on reclosable packages shall comply with EN ISO standard 8317 as amended relating to ‘Child-resistant packages — Requirements and methods of testing for reclosable packages’ adopted by the European Committee for standardisation (CEN) and the International Standard Organisation (ISO).

3.1.3 Non-reclosable packages U.K.

Child-resistant fastenings used on non-reclosable packages shall comply with CEN standard EN 862 as amended relating to ‘Packaging — Child-resistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products’ adopted by the European Committee for Standardisation (CEN).

3.1.4 Notes U.K.

3.1.4.1. Evidence of conformity with the above standards may be certified only by laboratories which conform with Standard EN ISO/IEC 17025 as amended. U.K.

3.1.4.2. Specific cases U.K.

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test referred to in section 3.1.2 or 3.1.3 does not need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the national authority may ask the person responsible for putting the product on the market to give it a certificate from a certifying laboratory, referred to in section 3.1.4.1, stating that either:

• the type of closure is such that it is not necessary to perform the test referred to in section 3.1.2. or 3.1.3; or

• the closure has been tested and has been found to conform with the standards referred to above.

[F8 3.2 Tactile Warnings U.K.

3.2.1. Packaging to be fitted with a tactile warning U.K.

3.2.1.1. Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory sensitisation, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger. U.K.

3.2.1.2. Section 3.2.1.1 does not apply to transportable gas receptacles. Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard need not be fitted with a tactile warning unless they are classified for one or more of the other hazards in section 3.2.1.1. U.K.

3.2.2. Provisions relating to tactile warning U.K.

The technical specifications for tactile warning devices shall conform to EN ISO standard 11683 as amended ‘ Packaging — Tactile warnings of danger — Requirements ’ .]

Textual Amendments

F8 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).

[F9 3.3 Liquid consumer laundry detergents in soluble packaging for single use U.K.

Where a liquid consumer laundry detergent in dosages for single use is contained in a soluble packaging, the following additional provisions shall apply:

3.3.1.

Liquid consumer laundry detergents contained in soluble packaging for single use shall be contained in an outer packaging. The outer packaging shall fulfil the requirements of section 3.3.2 and the soluble packaging shall fulfil the requirements of section 3.3.3.

3.3.2.

The outer packaging shall:

(i)

be opaque or obscure so that it impedes the visibility of the product or individual doses;

(ii)

without prejudice to Article 32(3), bear the precautionary statement P102 ‘ Keep out of reach of children ’ at a visible place and in a format that attracts attention;

(iii)

be an easily reclosable, self-standing container;

(iv)

without prejudice to the requirements of section 3.1, be fitted with a closure that:

(a)

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(b)

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

3.3.3.

The soluble packaging shall:

(i)

contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;

(ii)

retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;

(iii)

resist mechanical compressive strength of at least 300 N under standard test conditions.]

Textual Amendments

F9 Inserted by Commission Regulation (EU) No 1297/2014 of 5 December 2014 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).

4. PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS U.K.

Without prejudice to the information required in accordance with [F10 Article 65 of Regulation (EC) No 1107/2009 and Regulation (EC) No 547/2011 as regards labelling requirements for plant protection products subject to Regulation (EC) No 1107/2009] shall also include the following wording:

Textual Amendments

F10 Words in Annex 2 Pt. 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. 56(c); 2020 c. 1, Sch. 5 para. 1(1)

EUH401 — ‘To avoid risks to human health and the environment, comply with the instructions for use’

5. PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES U.K.

• Ready mixed cement and concrete in the wet state.