Cosmetic Directive

The European Parliament has adopted a final project to recast the European Union’s legislation on cosmetics. The new text changes the rules applicable to nano-materials used in cosmetics, claims made for products, CMRs and in-market controls.

New EU cosmetics regulation: what’s changing?

After one reading, the European Parliament agreed on 24 March 2009 on a compromise text negotiated together with the Council and aiming at simplifying procedures while strengthening certain elements of the regulatory framework for cosmetics.

A Regulation to replace the Directive

The new legislation will take the form of a European Regulation, making it immediately enforceable as law in all EU member states simultaneously. At the difference of the Directive currently applicable to cosmetic products , the new text will not need to be transposed into national law in each member states, thus not giving room for diverging interpretations.

Strengthened in-market control

As part of the simplification of administrative procedures, the text creates a single EU-wide register for cosmetic products and increases the cooperation between market surveillance authorities.

In replacement of the various national procedures, the text introduces an EU-wide compulsory notification system of cosmetic products, including the obligation to declare the presence of substances in the form of nanomaterials before placing products on the market. The required information will be transmitted to the Commission through electronic means.

Undesirable side effects induced by cosmetic products will also be monitored at the European scale.

Compulsory labelling and safety assessment of nanomaterials

For the first time ever, a European legislation addresses nanoparticles as such. As requested by the European Parliament, the new regulation introduces a safety assessment procedure for all products containing nanomaterials, which could lead to a ban on a substance if there is a risk to human health.

Cosmetic products containing nanoparticules will have to be notified to the Commission six months prior being placed on the market. In case of concern regarding the safety of a nanomaterial, the Commision will have to seize the Scientific Committee on Consumer Safety (SCCS) for giving an opinion.

Members of European Parliament (MEPs) also pushed successfully for any nanomaterials present in cosmetics to be mentioned in the list of ingredients on the packaging. In the list of ingredients, concerned substances will be followed by the word “nano” in brackets (e.g.: Titanium dioxyde [nano]).

MEPs have also introduced a definition of a nanomaterial as “an insoluble or bioresistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”

This is the first time that a definition of nanomaterials is introduced in European law. The Commission will have to adapt this definition in line with scientific and technological advances. However, environmental organisations and the BEUC, the European consumers’ organisation, have criticised the s narrowness of the definition’s scope.

Common criteria for product claims

On the use of product claims for cosmetics, the Commission is asked to adopt a list determining common criteria. Such a list aims at harmonising the opinion of public authorities in the various member states concerning what claims are acceptable or unacceptable for cosmetic products.

Stricter rules on CMR substances

The regulation provides for strict rules for the use of substances which are carcinogenic, mutagenic or toxic for reproduction (CMR). The use of those substances is basically forbidden in cosmetics and they can only be used in exceptional cases under strict conditions, which have been tightened up by the compromise.

The proposed text also addresses substances with endocrine-disrupting properties, that will be regulated when European or internationally agreed criteria for identifying them or at the latest five years after the Regulation has entered into force.

Ban on animal testing unchanged

The existing provisions banning animal testing for finished cosmetic products as of 2004, with a phasing-out period for animal tests on cosmetic ingredients by 2009/2013, are unaffected by the new regulation.

Final steps

MEPs adopted the proposed regulation with 633 votes in favour, 29 against with 11 abstentions. The Council must now approve the same text so that it becomes law and comes into effect in 2012.

EU Regulatory Activities

1. Safety assessment (Art.10)

Prior to placing a cosmetic product on the market, the responsible person (Art. 4) shall ensure that the product has undergone a safety assessment and that a cosmetic product safety report is set up in accordance with Annex I.

2. Product Information File (Art. 11)

When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

3. Notification (Art.13)

Prior to placing the cosmetic product on the market, the responsible person shall submit, by electronic means, the information as defined in the Article 13.

4. Restrictions (Art.14)

(a) Prohibited substances – listed in Annex II; CMR of category 2 as per Article 15
(b) Restricted substances-substances which are not used in accordance with a type of restrictions as defined in Annex III:
b1: Restrictions based on product type
b2: Maximum concentration in ready to use preparation
b3: Other > General use and professional use-based restrictions

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