EU LEGISLATION

Regulation (EC) N° 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when placed on the EU market. It provides a robust, internationally recognized regime, which reinforces product safety while taking into consideration the latest technological developments, including the possible use of nanomaterials and meeting the ban of animal testing.

Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.

Only cosmetic products for which a legal or natural person is designated within the EU as a 'responsible person', can be placed on the market.

Manufacturers will need to notify their products only once via the EU cosmetic products notification portal (CPNP).

A responsible person will have an obligation to notify serious undesirable effects to national authorities and they will be also obliged to share the information with other EU countries.

Colorants, preservatives and UV-filters, including those that are nanomaterials must be explicitly authorized. Products containing other nanomaterials not otherwise restricted by the cosmetics regulation will be the object of a full safety assessment at EU level if the Commission has concerns. Nanomaterials must be labelled in the list of ingredients with the word 'nano' in brackets following the name of the substance, e.g. 'titanium dioxide (nano)'.

EU COSING

It is the EU COMMISSION database for information on ingredients & substances where CAS, ELINCS or EINECS numbers can be searched for.

Ingredient assigned with an INCI name that appears in the inventory section of CosIng does not mean it is to be used in cosmetic products nor approved for such use.

Concerning ingredients used in cosmetic products as colorants, preservatives and UV filters, only those authorized in Annexes IV, V, VI respectively to Cosmetic Regulation No 1223/2009 are listed in CosIng. CosIng may also list ingredients known to be used in medicinal products.

EU COSMETIC PRODUCTS CONTAINING NANOMATERIALS

The CPNP also contains a separate module for cosmetic products containing nanomaterials. This notification has to be done 6 months prior to the placing on the market of the cosmetic product. If the European Commission has concerns regarding the safety of a nanomaterial, it may request the scientific committee on consumer safety to perform a risk assessment.

In cosmetic products, reference to 'nanotechnology' usually means the use of insoluble nanoparticles as ingredients.

EU COSMETIC PRODUCTS CONTAINING CMRs

Cosmetics legislation also contains provisions on using carcinogenic, mutagenic, or toxic for reproduction substances ( CMR substances ) in cosmetic products. In general, the use of CMR substances is prohibited, except for in exceptional cases.

EU ENDOCRINE DISRUPTORS

Endocrine Disruptors (ED) are chemicals that may interfere with the hormonal system and, as a result of that, produce harmful effects in both humans and wildlife.

The regulation includes a system of restrictions on and bans of certain substances in cosmetics. Restrictions are based on the scientific committee on consumer safety's (SCCS) risk assessments. These assessments address scientific concerns about the endocrine-disrupting properties of substances in cosmetics as well as other substances of concern.

>> Refer to Endocrine Disruptors page .

EU BAN ON ANIMAL TESTING

The legislation on cosmetic products defined a regulatory framework for the phasing out of animal testing for cosmetic purposes. Specifically, it established :

• a testing ban / prohibition to test finished cosmetic products and cosmetic ingredients on animals;
• a marketing ban / prohibition to market finished cosmetic products and ingredients in the EU which were tested on animals.
  • The testing ban on finished cosmetic products applies since 11 September 2004 .
  • The testing ban on ingredients or combination of ingredients applies since 11 March 2009.
  • The marketing ban applies since 11 March 2009 for all human health effects with the exception of repeated-dose toxicity, reproductive toxicity, and toxicokinetics.
  • For these specific health effects, the marketing ban applies since 11 March 2013 , irrespective of the availability of alternative non-animal tests.

EU MICROPLASTICS

ECHA – REACH ANNEX XV RESTRICTION REPORT (PROPOSAL FOR A RESTRICTION)

The ECHA proposal for Cosmetics is currently the following:

• Ban on microbeads as soon as Restriction comes into effect (EIF).
• Ban for microplastics in Rinse Off cosmetics products with 4 year transition period (Enter into Force date + 4 years).
• Ban for microplastics in Leave On cosmetics products with 6 years transition period (Enter into Force date + 6 years).
• The future legislation is expected by the end of 2020 (third quarter?).

>> Information provided from the official website from the European Union .