Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title

CHAPTER X IMPLEMENTING MEASURES, FINAL PROVISIONS

Article 31 Amendment of the Annexes

1. Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4).

2. The Commission may, after consulting the SCCS, amend Annexes III to VI and VIII for the purposes of adapting them to technical and scientific progress.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

3. Where it appears necessary, in order to ensure the safety of cosmetic products placed on the market, the Commission may, after consulting the SCCS, amend Annex I.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

Article 32 Committee procedure

1. The Commission shall be assisted by the Standing Committee on Cosmetic Products.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

Article 33 Glossary of common ingredient names

The Commission shall compile and update a glossary of common ingredient names. To this end, the Commission shall take account of internationally recognised nomenclatures including the International Nomenclature of Cosmetic Ingredients (INCI). That glossary shall not constitute a list of the substances authorised for use in cosmetic products.

The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve months after publication of the glossary in the Official Journal of the European Union.

Article 34 Competent authorities, poison control centres or assimilated entities

1. Member States shall designate their national competent authorities.

2. Member States shall communicate the details of authorities referred to in paragraph 1 and of the poison centres and similar bodies referred to in Article 13(6) to the Commission. They shall communicate an update of these details as necessary.

3. The Commission shall compile and update a list of the authorities and bodies referred to in paragraph 2 and make it available to the public.

Article 35 Annual report on animal testing

Every year the Commission shall present a report to the European Parliament and the Council on:

(1)

progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Directive 86/609/EEC. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;

(2)

progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;

(3)

the manner in which the specific needs of small and medium-sized enterprises have been taken into account.

Article 36 Formal objection against harmonised standards

1. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall deliver its opinion without delay.

2. In the light of the Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

3. The Commission shall inform the Member States and the European standardisation body concerned. It shall, if necessary, request the revision of the harmonised standards concerned.

Article 37 Penalties

Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.

Article 38 Repeal

Directive 76/768/EEC is repealed with effect from 11 July 2013, with the exception of Article 4b which is repealed with effect from 1 December 2010.

References to the repealed Directive shall be understood as references to this Regulation.

This Regulation shall be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.

However, the competent authorities shall continue to keep available the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC and responsible persons shall continue to keep readily accessible the information collected pursuant to Article 7a of that Directive until 11 July 2020.

Article 39 Transitional provisions

By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.

As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive.

Article 40 Entry into force and date of application

1. This Regulation shall enter into force on the [twentieth day after its publication in the Official Journal of the European Union

2. It shall apply from 11 July 2013, with the exception of:

• Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and

• Article 16(3) second subparagraph, which shall apply from 11 January 2013.