Cosmetics responsible person EU
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EU Regulation 1223/2009 mandates that cosmetic products have a designated 'responsible person' within the EU for market compliance and safety assurance. The responsible person must ensure compliance with various regulatory obligations and maintain a product information file accessible to authorities. Professional responsible persons can be appointed for expertise, providing a single contact point for regulatory issues and ensuring ongoing compliance.
Cosmetics responsible person EU
- 1. EU REGULATION 1223/2009 © CE.way Regulatory Consultants Ltd
- 2. LEGISLATION • EU cosmetic regulation 1223/2009 (replacing directive 76/768/EC) • Applicable: July 2013 onwards © CE.way Regulatory Consultants Ltd
- 3. WHO IS A RP AND WHY IS HE NEEDED? Regulation 1223/2009: • “Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market” • “In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community” • “For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located” © CE.way Regulatory Consultants Ltd
- 4. WHO IS A RP AND WHY IS HE NEEDED? • A natural or legal person • Responsible person has to be established within the EU • Without a responsible person, cosmetic products can’t be placed on the EU market • There has to be only 1 responsible person designated per cosmetic product © CE.way Regulatory Consultants Ltd
- 5. WHO CAN ACT AS A RESPONSIBLE PERSON? Responsible person can be one of the following (has to be EU based): • Product manufacturer • Product importer • Product distributor • A person/company designated as a responsible person (has to accept this role in writing) © CE.way Regulatory Consultants Ltd
- 6. WHO CAN ACT AS A RESPONSIBLE PERSON? Responsible person can be one of the following (has to be EU based): • Product manufacturer EU BASED MANUFACTURER • Product importer • For products manufactured within the EU (by an EU based • Product distributor manufacturer) and not subsequently exported and • A person/company imported back into the EU, the designated as a manufacturer shall be the responsible person responsible person (has • However, the manufacturer can to accept this role in designate a person established in the EU as a responsible person writing) © CE.way Regulatory Consultants Ltd
- 7. WHO CAN ACT AS A RESPONSIBLE PERSON? Responsible person can be one of the following (has to be EU based): • Product manufacturer NON-EU BASED MANUFACTURER • Product importer • For products manufactured • Product distributor within the EU (by a non-EU based manufacturer) and not • A person/company subsequently exported and designated as a imported back into the EU, the responsible person (has manufacturer shall designate a to accept this role in person established in the EU as a writing) responsible person © CE.way Regulatory Consultants Ltd
- 8. WHO CAN ACT AS A RESPONSIBLE PERSON? Responsible person can be one of the following (has to be EU based): • Product manufacturer IMPORTER • Product importer • For products manufactured • Product distributor outside the EU and imported into the EU, the importer shall be the • A person/company responsible person designated as a • However, the importer can responsible person (has designate a person established in to accept this role in the EU as a responsible person writing) © CE.way Regulatory Consultants Ltd
- 9. WHO CAN ACT AS A RESPONSIBLE PERSON? Responsible person can be one of the following (has to be EU based): • Product manufacturer DISTRIBUTOR • Product importer • If a distributor placed a cosmetic product on the market under his • Product distributor name or trademark or modifies* a product already placed on the • A person/company market in such a way that compliance with the applicable designated as a requirements will be affected, the distributor shall be the responsible responsible person (has person to accept this role in • *Translation of the information relating to the product shall not be writing) considered as such a modification © CE.way Regulatory Consultants Ltd
- 10. WHO CAN ACT AS A RESPONSIBLE PERSON? COSMETIC PRODUCTS ARE COSMETIC PRODUCTS PRODUCED OUTSIDE THE ARE PRODUCED AND EU AND SOLD IN THE EU SOLD IN THE EU (IMPORTED) MANUFACTURER (EU Manufacturer OR / BASED) a designated person Importer OR IMPORTER / a designated person DISTRIBUTOR Distributor* Distributor* MANUFACTURER A designated person A designated person (NON-EU BASED) *Under specific conditions explained earlier © CE.way Regulatory Consultants Ltd
- 11. RESPONSIBLE PERSON RESPONSIBILITIES • “For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation” (Regulation 1223/2009, Article 4.2) • “Responsible person shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Regulation 1223/2009, Article 5.1) © CE.way Regulatory Consultants Ltd
- 12. RESPONSIBLE PERSON RESPONSIBILITIES Article Referring to Article Referring to 3 Safety 16 Nanomaterials Traces of prohibited 8 Good manufacturing practice 17 substances 10 Safety assessment 18 Animal testing 11 Product information file 19 Labeling 12 Sampling and analysis 20 Product claims Access to information for the 13 Notification 21 public Restriction for substances Communication of serious 14 23 listed in the Annexes undesirable effects Substances classified as CMR 15 24 Information on substances substances © CE.way Regulatory Consultants Ltd
- 13. RESPONSIBLE PERSON RESPONSIBILITIES Most important functions: • Ensure that the product is safe and compliant with the regulation • Immediately inform the competent authorities if a cosmetic product represents a risk to human health • If necessary, take any appropriate measures to bring the product into conformity • Cooperate with the EU competent authorities at their request • In the event of serious undesirable effects, notify the competent authority of the Member State where the serious undesirable effect occurred © CE.way Regulatory Consultants Ltd
- 14. RESPONSIBLE PERSON RESPONSIBILITIES • Product information file (PIF) Keep PIF for products placed on the EU market Make it readily accessible to the competent authority of the Member State in which the file is kept At his address indicated on the label Ensure the PIF is updated at all times • Perform the notification to CPNP prior to placing the cosmetic product on the EU market • Notify the cosmetic products containing nanomaterials to the Commission 6 months prior to being placed on the EU market © CE.way Regulatory Consultants Ltd
- 15. A PROFESSIONAL RESPONSIBLE PERSON • Responsible, demanding task, which requires expertise in various areas • Manufacturers or importers may outsource this function to a professional responsible person Must be designated by a written mandate, and has to accept this role in writing • Professional cosmetics responsible person is a person or a company, who is an expert in the cosmetics regulation © CE.way Regulatory Consultants Ltd
- 16. WHY A PROFESSIONAL RESPONSIBLE PERSON? An expert in the cosmetics regulation • Keeping track of the ever changing EU legislation • Single contact point for any regulatory issue in the EU • Helping to compile the PIF fast and accurately, enabling to put the products on the EU market quicker • Making sure the products are compliant with the regulation, therefore “keeping you out of trouble” © CE.way Regulatory Consultants Ltd
- 17. WHY A PROFESSIONAL RESPONSIBLE PERSON? • Even if importers change, RP remains the same, eliminating the need to reprint the product labels and to renotify your products • Able to represent companies in front of the EU competent authorities, handle any questions from them, or any crisis that might arise • Treat PIF with care, keeping all the product secrets confidential • PIF has to be kept by the RP for 10 years after the last batch of the product has been placed on the market • Neutral - has no conflict of interest with client’s commercial interests © CE.way Regulatory Consultants Ltd
- 18. www.ceway.eu info@ceway.eu © CE.way Regulatory Consultants Ltd