Directive 1999/45/EC of the European Parliament and of the Council (repealed)Dangos y teitl llawn

Article 10 U.K. Labelling

1.1. Member States shall take all necessary measures to ensure that:

(a)

preparations within the meaning of Article 1(2) cannot be placed on the market unless the labelling on their packaging satisfies all the requirements of this Article and the specific provisions of Part A and B of Annex V;

(b)

preparations within the meaning of Article 1(3) as defined in Parts B and C of Annex V cannot be placed on the market unless the labelling on their packaging satisfies the requirements of paragraphs 2.1 and 2.2 and the specific provisions of Parts B and C of Annex V.

1.2. With respect to plant protection products subject to Directive 91/414/EEC, the labelling requirements in accordance with this Directive shall be accompanied by the following wording: ‘To avoid risks to man and the environment, comply with the instructions for use.’

This labelling shall be without prejudice to the information required in accordance with Article 16 of, and Annex V to, Directive 91/414/EEC.

2. The following information shall be clearly and indelibly marked on any package:

2.1. the trade name or designation of the preparation;

2.2. the name, full address and telephone number of the person established in the Community who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;

2.3. the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules:

2.3.1. for preparations classified T⁺, T, X_n in accordance with Article 6, only the substances T⁺, T, X_n present in concentrations equal to, or greater than, the lowest limit (limit X_n) for each of them laid down in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or, failing that, Part B of Annex II to this Directive have to be taken into consideration;

2.3.2. for preparations classified C in accordance with Article 6, only C substances present in concentrations equal to, or greater than, the lowest limit (limit X_i) laid down in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or, failing that, Part B of Annex II to this Directive have to be taken into consideration;

2.3.3. the name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories:

• 2.3.3. carcinogen category 1, 2 or 3,

• mutagen category 1, 2 or 3,

• toxic for reproduction category 1, 2 or 3,

• very toxic, toxic or harmful due to non-lethal effects after a single exposure,

• toxic or harmful due to severe effects after repeated or prolonged exposure,

• sensitising;

shall be mentioned on the label.

The chemical name shall be one of the designations listed in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or an internationally recognised chemical nomenclature if no corresponding designation is yet listed in that Annex.

2.3.4. As a consequence of the above provisions the name of any substance which led to the classification of the preparation in the following danger categories:

• 2.3.4. explosive,

• oxidising,

• extremely flammable,

• highly flammable,

• flammable,

• irritant,

• dangerous for the environment,

need not be mentioned on the label unless the substance has to be mentioned pursuant to paragraphs 2.3.1, 2.3.2 or 2.3.3.

2.3.5. As a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary.

2.4. The danger symbol(s) and indication(s) of danger

2.4. The danger symbols, where specified in this Directive, and indications of the dangers involved in the use of the preparation, shall be in accordance with the wording of Annexes II and VI to Directive 67/548/EEC and shall be applied in accordance with the evaluation of the hazards carried out in accordance with Annexes I, II and III to this Directive.

2. Where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol:

• 2.4. T shall make the symbols C and X optional unless otherwise specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008],

• C shall make the symbol X optional,

• E shall make the symbols F and O optional,

• X_n shall make the symbol X_i optional.

2. The symbol(s) shall be printed in black on an orange-yellow background.

2.5. The risk phrases (R phrases)

2.5. The indications concerning special risks (R phrases) shall comply with the wording in Annexes III and VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II, and III to this Directive.

As a general rule, a maximum of six R phrases shall suffice to describe the risks; for this purpose, the combined phrases listed in Annex III to Directive 67/548/EEC shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases more than six R phrases may be necessary.

The standard phrases ‘extremely flammable’ or ‘highly flammable’ need not be used where they describe an indication of danger used in accordance with 2.4.

2.6. The safety advice (S phrases)

2.6. The indications giving safety advice (S phrases) shall comply with the wording in Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II and III to this Directive.

As a general rule, a maximum of six S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in Annex IV to Directive 67/548/EEC shall be regarded as single phrases. However, in some cases more than six S phrases may be necessary.

Where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation.

2.7. The nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public.

3. [F2 In relation to certain preparations classified as dangerous within the meaning of Article 7, by way of derogation from points 2.4, 2.5 and 2.6 of paragraph 2 of this Article, the Commission may determine exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling, where it can be demonstrated that there would be a reduction in the environmental impact. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20a(3).] These exemptions or specific provisions are defined and laid down in Part A or B of Annex V.

4. If the contents of the package do not exceed 125 ml:

• in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, or dangerous for the environment and assigned the N symbol it shall not be necessary to indicate the R phrases or the S phrases,

• in the case of preparations that are classified as flammable or dangerous for the environment and not assigned the N symbol it shall be necessary to indicate the R phrases but it shall not be necessary to indicate the S phrases.

5. Without prejudice to Article 16(4) of Directive 91/414/EC, indications such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statement indicating that the preparation is not dangerous or likely to lead to underestimation of the dangers of the preparation in question shall not appear on the packaging or labelling of any preparation subject to this Directive.

Textual Amendments

F1 Substituted 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).

F2 Substituted by Regulation (EC) No 1137/2008 of the European Parliament and of the Council of 22 October 2008 adapting a number of instruments subject to the procedure laid down in Article 251 of the Treaty to Council Decision 1999/468/EC, with regard to the regulatory procedure with scrutiny Adaptation to the regulatory procedure with scrutiny — Part One.