EU guidelines for cosmetic labelling and packaging

1. DELHI PHARMACEUTICAL SCIENCES AND
RESEARCH UNIVERSITY
SUMMARY OF FEATUESOF EU GUIDELINES FOR COSMETICS : LABELLING &
THE PRODUCT INFORMATION PACKAGE
PRESENTED BY PRESENTED TO
KUMARI SUPRIYA DR. KEERTI JAIN
M.PHARMA ASSOCIATE PROFESSOR
COSMECEUTICS (II SEM)

2. EUROPEAN UNION
• INTRODUCTION :- The European Regulation 1223/2009 , which replaced
previous legislation adopted by European countries, is the physiological
development of the early European directive (76/768/EEC) and its numerous
updates adopted over the years. This regulation intended to eliminate the
differences among the member States due to the scattered application of previous
laws, which complicated proper market surveillance.
• The labelling requirements of the Regulation become mandatory as of 11 July
2013 (Article40).

3. EUROPEAN UNION contd.
• OBJECTIVE :- The main goal of the latest update is consumer protection. The new
regulation, which has had immediate and binding application in all EU member States,
quite precisely identifies some aspects:-
Specific obligations of the person responsible for the product and its suppliers, with
reference to the traceability of the cosmetic product along its distribution chain.
Detailed cosmetic vigilance procedures.
Observance of the Good Manufacturing Practices (GMP).
• The new regulation introduced the obligation of electronic notification at the Cosmetic
Product Notification Portal (CPNP).

4. COSMETIC
• DEFINITION:- 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 odours.”

5. ROLE OF EU IN COSMETIC
• 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.
• These products are regulated at European level to ensure consumer safety and to
secure an internal market for cosmetics.

6. COSMETIC PRODUCT NOTIFICATION
PORTAL(CPNP)
• The Cosmetic Product 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.
• The CPNP is accessible to:-
Competent Authorities
European Poison Centres.
Cosmetic products responsible persons.
Distributors of cosmetic products.

7. GUIDELINES FOR LABELLING
REQUIREMENT
• NAME AND ADDRESS OF RESPONSIBLE PERSON :- 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".{Article19[1](a)}
• Responsible person can be as 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.

8. GUIDELINES FOR LABELLING
REQUIREMENT contd.
• 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.
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.

9. GUIDELINES FOR LABELLING
REQUIREMENT contd.
• 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).
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.
CONTENTS MINIMUM HEIGHT OF
FIGURES
Not exceeding 50g or 50ml 2mm
Exceeding 50g or 50ml but not exceeding 200g or 200ml 3mm
Exceeding 200g or 200ml but not exceeding 200g or 200ml 4mm
Exceeding 1kg or 1ml 6mm

10. GUIDELINES FOR LABELLING
REQUIREMENT contd.
• DATE OF MINIMUM DURABILITY AND PERIOD AFTER OPENING:-
On the basis of finished product physicochemical and microbiological stability studies,
two different situations have to be considered:-
The finished product has a minimum durability of less than or equal to 30 months.
The date of minimum durability shall be clearly expressed and preceded by the
mention “best used before the end of” or by the following symbol, specified in Annex
VII of the Regulation:{Article[1](c)}

11. GUIDELINES FOR LABELLING
REQUIREMENT contd.
The date consists either of the month and year (MMYYYY or MMYY) or the day,
month and year (DDMMYYYY or DDMMYY), in that order.
If the date is not located next to the symbol or next to the “best used before the end
of” sentence, its location has to be clearly explained.
And also mention storage condition of cosmetic.
An indication of the period of time after opening for which the product is safe and can
be used without any harm to the consumer must be labelled using the symbol
representing an open cream jar shown in point 2 of Annex VII:

12. GUIDELINES FOR LABELLING
REQUIREMENT contd.
The symbol must be accompanied by an indication of the period of time in months or
years shown as a number, which can be located inside or outside the symbol.
And in this indication ‘M’ indicates months like, “xM”.
• PARTICULAR PRECAUTIONS/WARNING:-
Article 19.1(d) requires that specific precautions to be observed during the use of
cosmetic products must be indicated on cosmetic product labels. Warnings required by
the Regulation are laid down in Annexes III to VI column i){Article[1(d)]}.
Example: In Johnson’s Baby powder – “For external use only ,Keep powder away from
children’s nose & mouth to avoid accidental inhalation .Discontinue use if skin irritation
occurs”.
This shall be referred to either by abbreviated information or by the “hand-in-book”
symbol which must appear on the container or packaging.

13. GUIDELINES FOR LABELLING
REQUIREMENT contd.
• The information shall be mentioned on an enclosed or attached leaflet, label tape, tag or
card.
• BATCH NUMBER:-
The batch number of manufacture or the reference for manufacturing identification of
the cosmetic product is a combination of letters and/or figures.
The Regulation does not specify the format for the batch number; the decision belongs to
the responsible person.{Article[1(f)]}

14. GUIDELINES FOR LABELLING
REQUIREMENT contd.
The purpose of the batch number is to ensure identification of a certain batch of a
cosmetic product throughout the whole supply chain, in particular in the rare case of a
recall.
The batch number has to be printed on both the container and the packaging. Where this
is impossible for practical reasons because the products are too small, it can be printed
only on the packaging.

15. GUIDELINES FOR LABELLING
REQUIREMENT contd.
• PRODUCT FUNCTION:-
The function of the cosmetic product should be clearly printed on the container and on
the packaging, unless it can be spontaneously and obviously deducted from a
combination of:
the product presentation (shape, size and volume) e.g. lipstick; - its name (e.g. cream),
trademarks; - its claims, pictures, logos and figurative or other etc.{Article[1(f)]}

16. GUIDELINES FOR LABELLING
REQUIREMENT contd.
• LIST OF INGREDIENT:-
The purpose of ingredient labelling is to ensure transparency to the consumer, giving
adequate information about the product.
The common name for ingredient labelling referred to in the EU regulation is known
as the International Nomenclature Cosmetic Ingredient name or INCI name.
The ingredients list must be visible to the consumer at the time of purchase.
Therefore, it can be placed on the packaging only.{Article[1(g)]}

17. GUIDELINES FOR PACKAGING
REQUIREMENT contd.
• EU regulations now require that companies have a Product Information File (PIF) for
each product sold on the market and this PIF must be available to authorities at the
address on the package (if requested).
• One of the critical components of the PIF is the Cosmetic Safety Report. This report
demonstrates the safety of the product, including its packaging.

18. GUIDELINES FOR PACKAGING
REQUIREMENT contd.
• The new Regulation defines that the packaging of cosmetic products is a key component
of the cosmetic product which must therefore meet high safety requirements in order to
ensure an appropriate level of protection of human health. Containers or packaging must
bear written information in indelible, easily legible and visible lettering.
• They must not contain impurities and chemicals prohibited in the EU that may be found
in the packaging and therefore may leach into the cosmetic product.

19. GUIDELINES FOR PACKAGING
REQUIREMENT contd.
• The packaging must contain following :-
The name or registered name and the address of the responsible person.
The country of origin for imported products.
The weight or volume of the content at the time of packaging.
A use-by date for products kept in appropriate conditions.
Precautions for use, including for cosmetics for professional use.
The batch number of product.
List of ingredients.
The language of the information shall be determined by the Member State where the
product is made available to the end user.

20. REFERENCES
• https://ec.europa.eu/growth/sectors/cosmetics_en.
• https://cosmeticseurope.eu/files/9314/7306/9079/Compliance_with_regulation_12
23-2009_new.pdf.
• https://www.happi.com/contents/view_experts-opinion/2014-11-17/eu-cosmetics-
packaging-requirements/.
• http://www.herrco.co.uk/downloads/Compliance/HC-
17CosmeticProductLabelling-EU.pdf.
• https://www.raepak.com/product-labelling-eu-cosmetic-safety-regulation-guide/.
• https://cosmeticseurope.eu/cosmetics-industry/understanding-cosmetics-
regulation/.