Transcript Responsible Person v. Safety Assessor

Responsible Person v. Safety Assessor
ECORE ERPA Seminar – Tel Aviv – 16 June 2014
Sylvie Gallage-Alwis
Avocat à la Cour / Solicitor in England & Wales
Overview
Regulation 1223/2009 dated 30 November 2009 – fully into force since 11
July 2013
•
Responsible person: "Only cosmetic products for which a legal or
natural person is designated within the Community as 'responsible
person' shall be placed on the market" (Art. 4)
• Safety assessor:
 "In order to demonstrate that a cosmetic product complies with Article 3,
the responsible person shall, prior to placing a cosmetic product on the
market, ensure that the cosmetic product has undergone a safety
assessment" (Art. 10)
 "a person in possession of a diploma or other evidence of formal
qualifications awarded on completion of a university course of theoretical
and practical study in pharmacy, toxicology, medicine or a similar
discipline, or a course recognised as equivalent by a Member State" (Art.
10)
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Responsible Person v. Safety Assessor
1. 2 key players for 1 top priority in the EU: the protection of the consumers
2. The definition of the Responsible Person and the Safety Assessor
3. The Roles of the Responsible Person and the Safety Assessor
4. The liabilities and risks that may be faced by the Responsible Person and the
Safety Assessor
5. The diverging interests of the Responsible Person and the Safety Assessor
6. The need for cooperation
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1. Top priority in the EU : protection of the
consumers
•
Regulation 1223/2009 - Article 1: "This Regulation establishes rules to be
complied with by any cosmetic product made available on the market, in order to
ensure the functioning of the internal market and a high level of protection of
human health".
•
2 key players :
the Responsible Person
the Safety Assessor
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2. Definition of the Responsible Person and the
Safety Assessor
Responsible Person (RP)
Article 4 of Regulation 1223/2009
Cosmetic product manufactured within the EU, by a
manufacturer established within the EU, not subsequently
exported and imported back in the EU :
The manufacturer shall be the RP
The manufacturer may designate by written
mandate, a person established within the EU
Imported cosmetic products :
Each importer shall be the RP of the product he
places on the market
The importer may designate by written mandate, a
person established within the EU
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Cosmetic product manufactured within the EU, by a
manufacturer established outside the EU, not subsequently
exported and imported back in the EU :
The manufacturer must designate by written
mandate, a person established within the EU
Cosmetic product placed on the market under the distributor's
name or trademark or product already placed on the market
modified by the distributor in such a way that compliance with
the applicable requirements may be affected :
The distributor shall be the RP
Safety Assessor
Article 10 of Regulation 1223/2009
"person in possession of a diploma or other evidence of formal qualifications awarded on completion of a
university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or
a course recognised as equivalent by a Member State"
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3. Roles of the Responsible Person and the
Safety Assessor
The Responsible Person:
• Ensures compliance of the product with the rules set out in the Regulation relating to:
 Human health
 Safety
 Consumer information
•
Maintains a product information file accessible to the public authorities
•
Ensures product traceability by identifying the distributors to whom they supply the cosmetic
product for a period of three years following the date on which the batch of the cosmetic
product was made available to the distributor (the same applies to all other persons
involved in the supply chain)
•
In case of non-compliance with the Regulation, takes corrective measures, withdraws the
product or recalls it
•
Informs the authorities if the product presents a risk to human health
The Safety Assessor:
• Carries out the cosmetic product safety assessment, as set out in Part B of Annex I of
Regulation 1223/2009
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List of the obligations of the Responsible Person
•
Safety (article 3)
•
Good manufacturing practices (article 8)
•
Safety assessment (article 10)
•
Product information file (article 11)
•
Sampling and analysis (article 12)
•
Notification (article 13)
•
Restrictions for substances listed in the Annexes (article 14)
•
CMR (article 15)
•
Nanomaterials (article 16)
•
Traces of prohibited substances (article 17)
•
Animal testing (article 18)
•
Labelling (article 19)
•
Product claims (article 20)
•
Access to information for the public (article 21)
•
Communication of serious undesirable effects (article 23)
•
Information on substances (article 24)
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How do they both contribute to the protection of
consumers?
The Responsible Person
•
•
•
•
Ensures safety of the product
Ensures market surveillance
Ensures transparency
Ensures cooperation with the
Authorities
The Safety Assessor
• Ensures safety of the product
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4. Liabilities
Principle of
liability of the
Responsible
Person
Share of liability
between the
Responsible
Person and the
Safety Assessor
concerning the
safety of the
product
Safety Assessor's
unique expertise
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What are the risks?
•
If the product does not comply with the Regulation or the good manufacturing
practices → even if no safety risk
•
If the product presents a safety risk
•
Sanctions to be established by each Member State
•
Civil liability
•
Contractual liability
•
Criminal liability
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Article 10 of Regulation 1223/2009
Responsible Person is liable for Annex I Part A
(Cosmetic Product Safety Report)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Quantitative and qualitative composition of the cosmetic
product
Physical/chemical characteristics and stability of the cosmetic
product
Microbiological quality
Impurities, traces, information about the packaging material
Normal and reasonably foreseeable use
Exposure to the cosmetic product
Exposure to the substances
Toxicological profile of the substances
Undesirable effects and serious undesirable effects
Information on the cosmetic product
Safety Assessor is liable for Annex I Part B
(Cosmetic Product Safety Assessment)
1.
2.
3.
4.
Assessment conclusion
Labelled warnings and instructions of use
Reasoning
Assessor's credentials and approval of part B
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Result type of obligation → as
soon as there is a noncompliance, liability is
incurred
Best efforts type of obligation →
the liability will be incurred if it is
shown that not all the
reasonably expected and
necessary steps were taken
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5. The diverging interests of the Responsible
Person and the Safety Assessor
Responsible Person
Safety Assessor
• Be 200% sure that the product
is compliant with the Regulation
• Make sure it has all the
appropriate data to carry out
its mission
• Have all data necessary to be
sure and answer the authorities
• Have its liability limited in case
of non-compliance
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• Have its liability limited in case
of non-compliance
• Be sure that the product will
not change after its
assessment
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Diverging interests = diverging clauses
Responsible Person
Safety Assessor
Limitation of liability clause
Detailed description of the
assessed product
Definition of the obligations of the
Safety Assessor
Involvement of the Safety Assessor
in case of control/claim
Information of the Safety Assessor
in case it looses its diploma or has
its liability at stake for another
product
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Limitation of liability clause
Definition of the information to be
provided by the Responsible
Person
Amendment of the contract in case
of further tests to be carried out
Obligation of the Responsible
Person to inform on any change in
the product/formula
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6. Cooperation between the Responsible Person
and the Safety Assessor
•
Diverging interests should not lead to a lack of cooperation
•
Cooperation is needed:

to set up the cosmetic product safety report
"Where the responsible person drawing up the cosmetic product safety report is not the
manufacturer of the product, they should ensure they have access to all the technical and
scientific skills necessary to obtain reliable cosmetic product safety information and an
appropriate safety assessment to demonstrate that the product they are responsible for is safe
[…]. They may therefore need to involve […] the safety assessor" (Guidelines on Annex I to
Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic
products)

to ensure that the safety of the product is properly assessed
"The responsible person and the safety assessor should work closely together to ensure that
the safety of the product is properly assessed and documented and that the assessment is kept
up to date. The responsible person and the safety assessor should gather all the necessary
information as required by Part A of Annex I to Regulation (EC) No 1223/2009" (Guidelines on
Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on
cosmetic products)
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Cooperation between the Safety Assessor and
the Responsible Person
 to ensure that the Safety Assessor has all
the data needed for the safety assessment
of the product
"Part A of the cosmetic product safety report is intended to
gather the data necessary to prove that the cosmetic product
is safe. The information should enable the safety assessor to
clearly identify and quantify, based on the identified hazards,
the risks a cosmetic product may present to human health".
"The responsible person, may consider that, depending on the
type of product, some of the required data are not relevant or
necessary to assess the safety of the product (e.g.
preservation challenge test). In this case, the absence of
specific data is to be clearly justified in Part A and the
justification is to be repeated and validated by the safety
assessor in their reasoning in Part B. The responsible person
should check the presence of the required data or the
justification for their absence". (Guidelines on Annex I to
Regulation (EC) No 1223/2009 of the European Parliament
and of the Council on cosmetic products)
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Questions
Contact:
Sylvie Gallage-Alwis
[email protected]
+33 1 53 67 47 47
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