This presentation explains who acts/can act as a cosmetics responsible person in in the EU and which are his duties.

1. EU REGULATION 1223/2009
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2. LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing
directive 76/768/EC)
• Applicable: July 2013 onwards
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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”
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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
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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)
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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)
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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
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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)
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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
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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
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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)
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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
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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
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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
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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
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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”
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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
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info@ceway.eu
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