Responsibilities & Obligations CPNP

Responsible person,
Distributors
Responsibilities & Obligations
Non-compliance
MONICA GABRIELA BAGHIU

http://www.consultantopportunities.com
Agenda
• Main actors of CPR
• Who is the Responsible Person?
• Main obligations of
– Responsible Person
– Distributors
• Examples of non-compliance
• Quiz

Main actors of CPR (1)
Manufacturer
Importer
Distributor
End user
Authority
MANUFACTURER
1. natural or legal person
2. manufactures a cosmetic
product, or has such a
product designed or
manufactured,
3. markets that cosmetic
product under his name or
trademark."
IMPORTER
1. natural or legal
person
2. established within the
Community,
3. places a cosmetic
product from a third
country on the
Community market.
DISTRIBUTOR
1. natural or legal person
in the supply chain,
2. other than the
manufacturer or the
importer
3. makes available a
cosmetic product on the
Community market

Main roles in CPR (1)
RESPONSIBLE PERSON (RP)
 a single person responsible for

ensuring compliance with the cosmetic
legislation
 1 cosmetic = 1 responsible person=1

address of cosmetic file;
 ‘Place on the market’ -the first

making available …on Community
market” (Art 2(h))
Main roles in CPR (2)
DISTRIBUTOR
 1 cosmetic = “n” distributors
 ‘Make available’ - any supply … for

distribution, consumption or use on the
Community market in the course of a
commercial activity, whether in return
for payment or free of charge”
(Art.2(g))

Who can act as RP ? (1)
Cosmetic product manufactured within the EU, not

subsequently exported and imported back in the EU
Manufacturer established within the EU:
- shall be the RP, (automatically attributed) or
- may designate by written mandate, a person
established within the EU (result from a contract)
Manufacturer established outside the EU:
- must designate by written mandate, a person
established within the EU (result from a contract)

Who can act as RP ? (2)
IMPORTER
- shall be the RP, (automatically attributed), or
- may designate by written mandate, a person established
within the EU (result from a contract);
DISTRIBUTOR shall be the RP if:
- places on the market a cosmetic product under his name
or trademark (automatically attributed);
- modifies a product already placed on the market in such a
way that compliance with the applicable requirements may
be affected (automatically attributed)

Obligations of RP (1)
Safety
Art.3
Sampling and analysis
Art.12
Safety
assessment
Art.10 Traces of prohibited
Claims substances Art.17
Art.20
Labelling Notification
Undesirable
Art.19 (1) (2) (5) Art.13
Effects
Art.23

Obligations of RP (2)
Information
on
substances
Art.24 Restrictions for
substances listed in
PIF the Annexes Art14
Art.11
Nanomaterials Animal testing Art18

Art16
GMP Access to
CMR
Art8 information
Art15
for the
public
Supply chain Art7
Art21

Obligations of distributors (1)
Shall act with due care in relation to applicable requirements
TO VERIFY:
— the labelling information (Art.6.(2):
the name or registered name and the address of the RP
the batch number of manufacture
the list of ingredients
— the language requirements (Art.6.(2):
— the date of minimum durability (Art.6.(2):

• To inform the RP and the competent national
authorities in case of a risk to human health
(Art.6(3);
• not to make available on the market and apply
corrective measures to bring that product into
conformity(Art.6(3);
• To ensure appropriate storage or transport
conditions(Art.6(4)
• shall cooperate with competent authorities
(Art.6(5)

• To identify RP or other distributors

within the supply chain (Art.6(3);
• To notify on CPNP a product having a
label translated by own initiative in order
to comply with national law (Art.13(3);
• To communicate about the serious
undesirable effects (SUE)
(Art.23(1)(3)
Safety of the product
Responsible person:
• to perform the safety evaluation of his
products or to have such evaluation made on
his behalf
• The safety of cosmetics must be assessed
prior to marketing
• To taking account of presentation including,
conformity with Directive 87/357/EEC
(Food imitating products)
Safety of the product
Distributors:
• To record in-market experience with
the cosmetic products they sell;
• To verify the conformity of the labelling;
• To ensure the safe handling and storage
• To cooperate with Member States’
authorities.
Good Manufacturing Practice
Responsible person:
• to demonstrate compliance by including a
statement in the PIF (CPR does not require
external certification to be obtained);
– Compliance will be presumed if GMP is in
accordance with an established harmonized
standard published in the OJEU
– harmonized standard = standard adopted by one
of the European standardization bodies listed in
Annex I to Directive 98/34/EC. (Art. 2(1)(j)
– CEN ISO 22716

Safety assessment (SA)
Responsible person :
• To ensure that SA has been performed by a
safety assessor;
• To follow all the recommendations of the
safety assessor (including to reject, or to
accept under specific conditions the
formulation)
– the liability concerning the safety assessment of
the product is shared between the Responsible
Person and the Safety Assessor
Product Information File-PIF
• To keep a PIF for each product placed on the market
• To make PIF readily accessible to the competent authority

of the MS in which the file is kept;
• To kept for an additional period of ten years following the

date on which the last batch was placed on the market
• To indicate the PIF address on the label;
• To ensure that PIF is up-dated
• To make available in a language which can be easily

understood by the competent authorities

Sampling and analysis
• To ensure compliance with sampling
and analysis:
– sampling and analysis should be carried out in
a reproducible and standardised manner
• standardised – in accordance with the relevant
harmonised standards

Notification
• To submit the information (related to the
product), prior to placing the cosmetic
product on the market.
Cosmetic Products Notification Portal
• Art. 13(1) – Notification by the
Responsible Person
• Article 13(3) – Notification by the
Distributor
Restrictions for certain substances (1)
Responsible person
To check that:
 No prohibited substances listed in the Annex
II are used
 No restricted substances are above the
allowed limit (Annex III column (g) are used;
 The label are in compliance with the
provisions of Annex III column (i); “Wording
of conditions of use and warnings”
Restrictions for certain substances (2)
Responsible person
Have to check that:
• colourants listed in Annex IV;
• Preservatives listed in Annex V ;
• UV-filters listed in Annex VI ;
are used in accordance with the corresponding

conditions laid down in CPR Annexes

Substances classified as CMR
Responsible person
To make no available on the market a cosmetic
product containing a substance which is classified as a
CMR substance, under Part 3 of Annex VI to the
Regulation (EC) No 1272/2008 (CLP Regulation), of :
• category 2, or
• category 1A or 1B,
unless there are met the conditions specified in Article
15(2) of CPR

Nanomaterials
Responsible person
• To notify on CPNP the cosmetic products that
contain nanomaterials, six months prior to their
placing in the market (Art.13), except:
– Ingredients listed specifically in their nano form in the
Annexes IV, V and VI
– nanomaterials, which meet the requirements set in the

Annex III;
• To label of all nanomaterials in the list of ingredients

Traces of prohibited substances
Responsible person
• shall be kept to a minimum, especially by
putting in place and applying the “As Low As
Reasonably Acceptable” (ALARA) principle
• To identify and to assess an unwanted
trace substance
• To justify and to give a proof of "technically
unavoidable" prohibited substances
Animal testing
Responsible person:
To ban on testing of
• finished cosmetic
• ingredients or combinations of ingredients
To include in the PIF the data on any animal testing
• performed by the manufacturer, agents or suppliers
and
• performed to meet the regulatory requirements of
third countries
or
• a statement indicating that no animal testing has
been conducted
Labelling (1)
Responsible person
• To ensure compliance with labelling
requirements.
• To include all particular precautions
decided to be labeled by the safety
assessor
• To comply with language
requirements.
Labelling (2)
Distributors
• To check the packaging of the products
• To verify that specific information is
present on the label,
• To verify whether certain information is in
the language required under the
applicable national law
Claim
Responsible person
In relation with Commission Regulation (EU)
No 655/2013:
- To build the claim (or consumer message)
- To provide sufficient evidence to
substantiate reasonable consumer
expectations of that claim;
- To ensure the quality of tests supporting
the claim
Access to information for the public
Responsible person
To ensure the public access to:
• qualitative and quantitative composition in
hazardous substances, according to Art. 3 of
Regulation (EC) No 1272/2008 (CLP)
• the name and code number, the identity of the supplier
of perfume and aromatic compositions
• existing data on undesirable effects and serious
undesirable effects

Communication of serious undesirable
effects (SUE)
Responsible person
• To ensure that he/she or the distributors shall
notify SUE without delay to competent authority
of MS involved;
• For this purpose:
– (1) To verify the existence of the UE and the
conditions under which the product was used (misuse
or not).
– (2) To verify the level of causality between the product
and the UE (i.e. assessment of whether the adverse
effect can be attributed to the use of the product
– (3) To determine the seriousness of the UE

Information on substances, regarding
the safety
Responsible person
To provide information upon a competent
authority in the case of :
• reasoned request from an authority (art.
5(3)
• Serious doubt regarding the safety of a
substance contained in cosmetic products
(art. 24)
General obligations of distributors
• to demonstrate the conformity of the

products upon request by an authority
(Art.6(5) e.g.: copy of the labels when the
authority requests proof of labelling
compliance
• to take appropriate measures in case
of non-conformity of a product. (art.26)

Examples of non-compliance
(distributor, label translation)
Original label “Translated” label
The product suits to all skin types, but The product suits to all skin types, but
it is particularly good for dry and it is particularly good for dry and
sensitive skin that need moisture. sensitive skin of adults and babies,
that need moisture. The cream is
helpful for all dry skin
conditions, particularly eczema
Used regularly they help restore the and dermatitis.
skin's smoothness, softness and Used regularly they help restore the
flexibility by helping the skin retain skin's smoothness, softness and
moisture. flexibility by helping the skin retain
It should be applied once a day, moisture.
particularly after washing, to prevent It should be applied twice a day,
the skin drying out. particularly after washing, to prevent
the skin drying out.
Non-compliance: Different Safety assessment (introducing babies and
other frequency of use), not cosmetic (prevent
MONICA GABRIELA BAGHIU conditions, like eczema) and
copyright violation (thehttp://www.consultantopportunities.com
content of label is the property of manufacturer)
Examples of non-compliance
responsible person -Food-imitating product
Non-compliance with
Art. 3 of CPR
RAPEX notifications
Non-compliance, responsible person and
distributors, claim substantiation and
safety
Sun protection claim

(SPF15);
no UV filters
included in formula
Non-compliance with
art. 20 and art. 3 of
CPR
RAPEX
.notification

Non-compliance, responsible person, use of
prohibited substances listed in Annex II of CPR
Use of
clobetasol
propionate
listed in the
Annex II,
entry 300
Non
compliance
with art. 14 of
CPR
RAPEX
notification
Non-compliance, responsible person, use of
CMR substances
The product contain

ketoconazole 2%–
reprotoxic 1B
Non-compliance with
Art.15 of CPR

Quiz…
A company manufactures cosmetic products
for different customers. Who is RP?
• Each one of the customers selling cosmetic
products under their own name or brand is RP
Two companies imported the same product
manufactured outside EU by the same
manufacturer. Who must to be RP?
• Both of them. Art. 4(5) establishes that for an
imported cosmetic product, each importer shall be
the responsible person for the specific cosmetic
product he places on the market.

Responsibilities & Obligations CPNP

Загружено:

Сведения о документе

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Responsibilities & Obligations CPNP

Загружено:

Авторское право:

Доступные форматы

Responsible person,

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

RESPONSIBLE PERSON (RP)

 a single person responsible for

 1 cosmetic = 1 responsible person=1

 ‘Place on the market’ -the first

 1 cosmetic = “n” distributors

 ‘Make available’ - any supply … for

MONICA GABRIELA BAGHIU

Cosmetic product manufactured within the EU, not

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

Nanomaterials Animal testing Art18

MONICA GABRIELA BAGHIU

— the labelling information (Art.6.(2):

the name or registered name and the address of the RP

the batch number of manufacture

the list of ingredients

— the language requirements (Art.6.(2):

— the date of minimum durability (Art.6.(2):

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

• To identify RP or other distributors

MONICA GABRIELA BAGHIU

• To keep a PIF for each product placed on the market

• To make PIF readily accessible to the competent authority

• To kept for an additional period of ten years following the

• To indicate the PIF address on the label;

• To ensure that PIF is up-dated

• To make available in a language which can be easily

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

• colourants listed in Annex IV;

• Preservatives listed in Annex V ;

• UV-filters listed in Annex VI ;

are used in accordance with the corresponding

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

– nanomaterials, which meet the requirements set in the

• To label of all nanomaterials in the list of ingredients

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

MONICA GABRIELA BAGHIU

• to demonstrate the conformity of the

MONICA GABRIELA BAGHIU

Sun protection claim

MONICA GABRIELA BAGHIU

The product contain

MONICA GABRIELA BAGHIU

Вам также может понравиться