Professional Documents
Culture Documents
Distributors
Responsibilities & Obligations
Non-compliance
DISTRIBUTOR
Labelling Notification
Undesirable
Art.19 (1) (2) (5) Art.13
Effects
Art.23
GMP Access to
CMR
Art8 information
Art15
for the
public
Supply chain Art7
Art21
TO VERIFY:
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
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
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
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
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.
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
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
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
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
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
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
RAPEX notifications
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
Non-compliance, responsible person and
distributors, claim substantiation and
safety
RAPEX
.notification
Use of
clobetasol
propionate
listed in the
Annex II,
entry 300
Non
compliance
with art. 14 of
CPR
RAPEX
notification
MONICA GABRIELA BAGHIU
http://www.consultantopportunities.com
Non-compliance, responsible person, use of
CMR substances