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EU REGULATION 1223/2009




© CE.way Regulatory Consultants Ltd
LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing
  directive 76/768/EC)
• Applicable: July 2013 onwards




© CE.way Regulatory Consultants Ltd
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
www.ceway.eu
                info@ceway.eu
© CE.way Regulatory Consultants Ltd

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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