The document discusses regulations for cosmetics in the European Union. It covers several key points: 1) The EU has strict regulations to ensure consumer safety while promoting innovation in the cosmetics sector. Products must be notified to authorities and comply with all relevant laws. 2) Importing cosmetics to the EU is complex, requiring compliance with regulations. Products must not be dangerous or potentially harmful. 3) Manufacturers must maintain an up-to-date Product Information File with product details and make it available for review. Non-compliance can result in market withdrawal or legal penalties.

1. COSMETIC REGULATION IN EUROPEAN UNION
Cosmetics-Formulation Science
By:
Mohd Tanzeem
School of Pharmaceutical Sciences

2. The EU’s role in cosmetics
•Europe is a world leader in the cosmetics industry and dominant
cosmetics exporter. The sector is highly innovative and provides
significant employment in Europe.
•The EU’s involvement mainly concerns the regulatory framework for
market access, international trade relations, and regulatory
convergence. These all aim to ensure the highest level of consumer
safety while promoting the innovation and the competitiveness of this
sector.
•The European Commission is also in contact with cosmetics
stakeholders at EU and international level. This cooperation enables
the exchange of information and ensures the smoother implementation
of EU requirements in the sector.

4. Marketing of your products requires:
•Informing the European Commission of your products. This process
is made possible by the New European Products Notification Portal
(CPNP).
•Availability of the Product Information File (PIF), whose
accessibility must be available at the products address (also listed on
the label).
• Consistent updates to the PIF as they become necessary.
•Compliance with all laws and regulations that control law

5. IMPORT OF COSMETICS IN EU
•Importing a foreign cosmetic brand into the European Union is a
complex process requiring compliance with strict regulations.
Furthermore, the ability to sell under the label of ‘organic’ requires
surpassing even more regulatory standards.
•All regulations are designed to protect consumers and cosmetic
sellers must be in compliance with these standards in order to sell their
products within the EU.
•Although it is necessary for pharmaceutical products, marketing
authorization is not necessary for cosmetics in France and Europe. The
product, however, must be in compliance with regulations that
ensure they are in no way dangerous or potentially harmful to the
health of those who will use them.

6. Cosmetic Products Notification Portal (CPNP)
The Cosmetic Products Notification Portal (CPNP) is a free of charge online
notification system created for the implementation of Regulation (EC) No 1223/2009
on cosmetic products. When a product has been notified in the CPNP, there is no need
for any further notification at national level within the EU.
Regulation (EC) No 1223/2009 (Article 13) requires that the responsible persons and,
under certain circumstances, the distributors of cosmetic products submit some
information about the products they place or make available on the European market
through the CPNP.
The CPNP is making this information available electronically to:
•Competent Authorities (for the purposes of market surveillance, market analysis,
evaluation and consumer information)
•Poison Centres or similar bodies established by EU countries (for the purposes of
medical treatment).

7. The CPNP is accessible to:
•Competent Authorities
•European Poison Centres
•Cosmetic products responsible persons
•Distributors of cosmetic products.
Products containing nanomaterials
The CPNP also contains a separate module (Article 16) for cosmetic products
containing nanomaterials.This notification has to be done in addition to the
notification under Article 13. If the European Commission has concerns regarding
the safety of a nanomaterial, it may request the Scientific Committee on
Consumer Safety to perform a risk assessment.

8. INFORMATION REGARDING THE PIF
• The marketer is responsible for the maintenance of an up-to-date Product
Information File (PIF).This file must be readily available for review at the address
provided on the product label.
• The PIF must include information relating to the components of the product, its
safety and its quality. So also, any potential negative side effects must be explained
and the expected effect (purpose) of the product must be included.
• Products manufactured within the European Union are under the responsibility of
the person or company selling the cosmetic as their brand. Products that are
imported from outside of the EU are under the responsibility of the importer.

9. The PIF must include:
 Explanation of the cosmetic.
 Details pertaining to the product’s safety. This includes:
• Product Make-up that identifies all ingredients and chemical additions.
• Product characteristics o Information regarding the Challenge Test o Source
and details of packaging material.
• Any possible negative side effects that may occur from product use.
• Details regarding the safety testing o The manufacturing process and
declaration of good manufacturing practice.
• Evidence of product claim veracity.

10. • The PIF must be available for verification at any moment. Therefore it
must be up to date and continually available for review by authorities and
regulators. Listed are three reliable and well-known inspection
organizations:
1.Inspectors of the ANSM (Agence Nationale de Sécurité du Médicament)
2.Inspectors from the Ministry of Health
3.Inspectors of the Department of Direction of Protection of the
Populations.
• Resistance to comply with regulations and availability of PIF can result in
market withdrawal, charges, and imprisonment.
• Those wishing to navigate the process on their own need to know and
understand the various regulations so that they can legally produce and sell
their products in the EU.

11. • According to Regulation (EC) No 1223/2009 of the European Parliament
and of the Council of 30 November 2009 on cosmetic products cosmetic
products are , “substances or mixtures of substances intended to be placed
in contact with the external parts of the human body (epidermis, hair
system, nails, etc.) or with the teeth and the mucous membranes of the oral
cavity with a view exclusively or mainly to cleaning them, perfuming them,
changing their appearance, protecting them, keeping them in good
condition or correcting body odors.”
• The movement and sale of these products within the EU is lawful only
when such movement is in compliance with Regulation No 1223/2009.
• To ensure market compliance, a responsible person within the community,
who is knowledgeable in market regulations, must be designated for each
product sold. So also, for a period of three years after product production,
the product must be traceable to its place of production

12. • This regulation ensures that in the case of any ‘bad’ product, thorough
investigation of said product’s source will be possible.
• A product’s designated ‘responsible person’ will be held accountable for the
availability of such information. Furthermore, the responsible person must
ensure that any necessary product recall is advertised and withdrawn from the
market.
• Annexes II and III provide an extensive list of prohibited and restricted
colorants, preservatives, and UV filters. These lists are intended to ensure that
only cosmetics products of the highest quality and safety standards are made
available to consumers within the EU.

13. • Proper product labelling is also required of cosmetics. Labels must be
written legibly in permanent ink to ensure that consumers are aware of the
product makeup both before and after they purchase. This requirement
further enforces the safety standards of product production and holds
producers accountable for ingredients used in and with the production of
their products.
• Annexes II and III provide an extensive list of prohibited and restricted
colorants, preservatives, and UV filters. These lists are intended to ensure
that only cosmetics products of the highest quality and safety standards are
made available to consumers within the EU.
• Proper product labelling is also required of cosmetics. Labels must be
written legibly in permanent ink to ensure that consumers are aware of the
product makeup both before and after they purchase.

14. • This requirement further enforces the safety standards of product
production and holds producers accountable for ingredients used in
and with the production of their products.
• To ensure that products are safe, before marketability and production
products must undergo a series of tests. Results of this information will
be provided on the PIF.

15. SPECIFIC GUIDANCE FOR EACH LABELLING
REQUIREMENT
1) Name and address of responsible person;
Country of origin Article 4 of the Cosmetics Regulation provides that, "only
cosmetic products for which a legal or natural person is designated within the
Community as „responsible person ‟ shall be placed on the market".
The responsible person can be one of the following:
• Manufacturer within the EU;
• Person designated by a manufacturer from outside the EU;
• Distributor if he modifies a product already on the market in such a way that
compliance with the Regulation may be affected (according to Articles 4 to 6);
• Importer (According to Articles 4 and 5);
• Third party with a written mandate from the manufacturer or the importer.
COLIPA GUIDELINESS ON COSMETIC PRODUCT LABELLING

16. The following information must be printed on both the container and the
packaging:
• Name & address of the responsible person.
• The name and address must be sufficient to allow the identification of and to the
access to the undertaking.
• The address may be abbreviated to a well-known city or town such that the
normal postal service will deliver a letter to that address.
• If the product is manufactured outside the EU, the country of origin must also be
labelled.
2) Nominal content
• The nominal quantities are expressed in units of weight or volume except in
specific cases (packaging containing less than five grams or five millilitres, and
others
• According to Directive 76/211/EC, Annex I, point 3.1, the nominal quantity
(nominal weight or nominal volume) is expressed in kilograms, grams, litres,
centilitres or millilitres. The minimum height of the figures is given in the
following table
COLIPA GUIDELINESS ON COSMETIC PRODUCT LABELLING

17. Contents Minimum height of
figures
Not exceeding 50 g or 50 ml 2 mm
Exceeding 50 g or 50 ml but not exceeding
200 g 0r 200 ml
3 mm
Exceeding 200 g or 200 ml but not
exceeding 1 kg or 1 l
4 mm
Exceeding 1 kg or 1 l 6 mm
3) Date of minimum durability (DOMD) and period after opening
(PAO)
 On the basis of finished product physicochemical and microbiological
stability studies, two different situations have to be considered:
a) The finished product has a minimum durability of less than or equal to
30 months
COLIPA GUIDELINESS ON COSMETIC PRODUCT LABELLING

41. Further Reading/Bibliography
SPS, DPSRU, New Delhi 41
1. Physical Pharmacy by Alfred Martin
2. Tutorial Pharmacy by Cooper and Gunn.
3. Stocklosam J. Pharmaceutical Calculations, Lea &Febiger,
Philadelphia.
4. Liberman H.A, Lachman C., Pharmaceutical Dosage forms,
Tablets, Volume-1 to 3, MarcelDekkar Inc.
5. Liberman H.A, Lachman C, Pharmaceutical Dosage forms.
Disperse systems, volume 1, 2, 3. Marcel Dekkar Inc.
6. Physical Pharmaceutics by Ramasamy C and ManavalanR.
7. Laboratory Manual of Physical Pharmaceutics, C.V.S.
Subramanyam, J. Thimma settee
8. Physical Pharmaceutics by C.V.S. Subramanyam
9. Test book of Physical Phramacy, by Gaurav Jain & Roop K. Khar