Ekotox Centers offer preparation of all documents required for registration of a cosmetic products and their for placing on the EU market according to the requirements of Regulation (EC) No. 1223/2009. We offer also services regarding to CPNP (Cosmetic Products Notification Portal) such a registration of the products and company account registration in CPNP.
EU Cosmetics Legislation and Requirements
On 11 July 2013 a new EU Regulation 1223/2009 (‘Cosmetic Products Regulation’) came into force strengthening the safety of cosmetic products and streamlining the framework for all operators in the sector.
The Cosmetics Regulation provides a robust, internationally recognised regime, which reinforces product safety taking into consideration the latest technological developments, including the possible use of nanomaterials. Previous ban and the strict regime aiming at phasing out animal testing were not modified.
The EU Cosmetic Products Regulation is a dinamic piece of legislation which is regurarly up-dated to ensure the highest standards of consumers and professionals safety.
During 2019, seven Adaptations to technical Progress (ATPs) to cosmetics regulation were published tu update the ingredients annexes.
Delegated Regulation (EU) 2020/217, adopted on October 4, 2019, has been published on February 18, 2020 as the 14th ATP (Adaptation to technical and scientific progress) of the CLP Regulation (Classification, Labelling and Packaging of Substances). It covers a total of six ingredients that can be used in cosmetic products, including titanium dioxide, which therefore officially becomes a carcinogen category 2 by inhalation.
The most significant priniples of the Cosmetics Regulation include:
- Strengthened safety requirements for cosmetic products
Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.
- The ‘responsible person’
Only cosmetic products for which a legal or natural person is designated within the EU as “responsible person” can be placed on the market. The new Cosmetics Regulation allows the precise identification of who the responsible person is and clearly outlines the obligations.
- CPNP – Centralized notification of all cosmetic products placed on the EU market
Manufacturer will need to notify its product only once – via the EU Cosmetic Products Notification Portal(CPNP).
- Reporting of serious undesirable effects
A responsible person will have an obligation to notify serious undesirable effects to competent national authorities. The authorities will also collect information coming from e.g. users and health professionals, and will be obliged to share the information with other EU Member States.
- New rules for the use of nanomaterials in cosmetic products
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 the 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)”.
Article 15 of Regulation (EC) N° 1223/2009 on cosmetic products (Cosmetics Regulation) lays down that substances which have been classified as carcinogenic, mutagenic or toxic for the reproduction (CMR) in Annex VI to Regulation (EC) 1272/2008 on classification, labelling and packaging of chemical substances and mixtures (CLP Regulation) shall be prohibited for use in cosmetic products, unless an exemption has been granted by the Commission (COM).
The exemption can be possibly granted only when industry has submitted an application for an exemption and where all the criteria for an exemption laid down in Article 15(1) or (2) of the Cosmetics Regulation are cumulatively fulfilled (i.e. positive assessment on the safe use by the Scientific Committee on Consumer Safety – SCCS, as well as, for CMR 1A/1B, compliance with food safety requirements, no suitable alternative substances available, application made for a particular use).
As regards the deadline for the implementation of the exemption procedure for CMR 1A/1B substances, Article 15(2) 4th subparagraph of the Cosmetics Regulation provides that the COM shall amend the relevant Annexes to this Regulation within 15 months of the “inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008”.
If you have questions please contact us by phone +421 2 45943712, or e-mail to ekotox(at)ekotox.sk.