Cosmetic Regulations in European Union

COSMETIC
REGULATION IN
EUROPEAN UNION
1

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.
http://ec.europa.eu/growth/sectors/cosmetics/
2

DEFINITION OF COSMETICS
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.”
3

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.
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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
http://www.cosmeticexportpro.com/single-post/2012/06/11/European-
Cosmetic-Import-Regulations
5

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).
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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.
7

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.
8

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.
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 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.
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 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
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 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.
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 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.
13

 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.
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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
2011 15

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
2011 16

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
2011 17

 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:
 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.
 If necessary, the information shall be supplemented by an indication of the conditions which must be
satisfied to guarantee the stated durability.
b) The finished product has a minimum durability of more than 30 months
 A date of minimum durability is not required. However, 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:
2011 18

 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.
 The European Commission and Member States have agreed on the use of M to represent months, but a
shortened version to represent the number of years has not been agreed. In practice, the indication is
usually given in months as “x M”.
4)Particular precautions / warnings
 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).
 Example: all toothpastes containing sodium fluoride must be labelled with the following wording:
“contains sodium fluoride”
 Specific precautions for use must be mentioned in the language(s) required by the Member States in
which the products are made available to end users (see Annex I of this document).
2011 19

 The precautions and warnings need to appear on both the container and the packaging. Where it is
impossible for practical reasons to print this information on the label, the information shall be mentioned
on an enclosed or attached leaflet, label tape, tag or card.
 This shall be referred to either by abbreviated information or by the “hand-in-book” symbol which must
appear on the container or packaging:
 Where it is impracticable to label the symbol, this may be omitted.
5) 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.
2011 20

 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.
6) 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.
2011 21

7) List of ingredients
 The purpose of ingredient labelling is to ensure transparency to the consumer, giving adequate
information about the product, for example allowing him or her to avoid ingredients that he/she may
be allergic to
 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
2011 22

GMP FOR COSMETICS IN EUROPE
 ISO 22716 is an International Standard which gives guidelines which are used as GMP guidelines in
Europe for the production, control, storage and shipment of cosmetic products.
 These guidelines cover the quality aspects of the product, but as a whole do not cover safety aspects for
the personnel engaged in the plant, nor do they cover aspects of protection of the environment.
 Safety and environmental aspects are inherent responsibilities of the company and could be governed by
local legislation and regulation.
 These guidelines are not applicable to research and development activities and distribution of finished
products.
ISO 22716:2007(E) 23

PERSONNEL HYGIENE AND HEALTH
 Hygiene programmes should be established and adapted to the needs of the plant. These requirements should be
understood and followed by every person whose activities take them into production, control and storage areas.
 Personnel should be instructed to use hand washing facilities.
 Every person entering production, control and storage areas should wear appropriate clothing and protective
garments to avoid contamination of cosmetic products.
 Eating, drinking, chewing, smoking or the storage of food, drink or smoking materials or personal medication in
the production, control and storage areas should be avoided.
 Steps should be taken to ensure, as far as is practicable, that any person affected by an apparent illness or having
open lesions on the exposed body surface should be excluded from entering into the production or storage area.
 Visitors or untrained personnel should preferably not be taken into production, control and storage areas.
ISO 22716:2007(E) 24

PREMISES
 Premises should be located, designed, constructed and utilized so as:
a) to ensure protection of the product;
b) to permit efficient cleaning, if necessary, sanitizing and maintenance;
c) to minimize the risk of mix-up of products, raw materials and packaging material
 Premises design recommendations are described in these guidelines. Design decisions should be
based on the type of cosmetic product produced, existing conditions, cleaning and, if necessary,
sanitizing measures used.
 Separate or defined areas should be provided for storage, production, quality control, ancillary,
washing and toilets.
 Sufficient space should be provided to facilitate operations such as receipt, storage and production.
ISO 22716:2007(E) 25

 Flow of materials, products and personnel through the building or buildings should be defined in order
to prevent mix-ups.
 Floors, walls, ceilings and windows in production areas should be designed or constructed for ease of
cleaning and, if necessary, sanitization and be kept clean and in good repair.
 Windows should be of non-opening design where ventilation is adequate. If windows are opened to
the outside environment, they should be properly screene
 New construction of production areas should incorporate considerations for proper cleaning and
maintenance.
 Adequate, clean, washing and toilet facilities should be provided for personnel. The washing and
toilet facilities should be differentiated from, but accessible to, production areas. Adequate facilities
for showering and changing clothes should be provided when appropriate.
ISO 22716:2007(E) 26

Equipment
 Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary,
sanitized and maintained.
 Production equipment should be designed to prevent contamination of the product.
 Bulk product containers should be protected from air contaminants, such as dust and moisture.
 Transfer hoses and accessories that are not in use should be cleaned and, if necessary sanitized, kept dry
and protected from dust, splash or other contamination.
 The material used in the construction of equipment should be compatible with products and the cleaning
and sanitizing agents.
 The design and the installation of equipment should ease its drainage in order to facilitate cleaning and
sanitization
ISO 22716:2007(E) 27

 Equipment should be placed so that movement of materials, mobile equipment and personnel do not
pose a risk to quality.
 All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme.
 Laboratory and production measuring instruments that are important for the quality of the product,
should be calibrated regularly.
ISO 22716:2007(E) 28

RAW MATERIALS AND PACKAGING MATERIALS
 Raw materials and packaging materials that are purchased should meet defined acceptance criteria
relevant to the quality of finished products
 Identification of raw materials and packaging materials should contain the following information:
a) name of the product marked on the delivery note;
b) name of the product as given by the company, if different from the name given by the supplier
and/or its
code number;
c) date or number of receipt, if appropriate;
d) supplier’s name;
e) batch reference given by the supplier and the one given at receipt, if different.
ISO 22716:2007(E) 29

 Storage conditions should be appropriate for each raw material and packaging material.
 Raw materials and packaging materials should be stored and handled in a manner appropriate to their
characteristics.
 Specific storage conditions should be respected and monitored, where appropriate.
 When raw materials and packaging materials are quarantined or rejected, they should be stored in their
respective physical locations or by using any other system providing the same level of assurance.
ISO 22716:2007(E) 30

PRODUCTION
 At each stage of manufacturing operations and packaging operations, measures should be taken to
produce a finished product that meets the defined characteristics.
 Relevant documentation should be available at each stage of manufacturing operations.
 Manufacturing operations should be carried out according to manufacturing documentation,
including:
a) suitable equipment;
b) formula for the product;
c) list of all raw materials identified according to relevant documents indicating batch numbers and
quantities;
d) detailed manufacturing operations for each stage, such as addition of raw materials, temperatures,
speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product
transfer.
ISO 22716:2007(E) 31

 Start-up checks like all documentation relevant to the manufacturing operations is available,all raw
materials are available and released, suitable equipment is available for use, in working order, cleaned
and, if necessary, sanitized, clearance of the area has been performed to avoid mixing with materials from
previous operations.
 Assignment of a batch number for identification of each of the batch incase of any problem.
 Re-stocking of packaging materials
 Identification and handling of work-in-process .Filling and labelling is usually a continuous process.
Where this is not the case, special measures including segregation and identification should be applied so
that no mix-ups or mislabelling can occur.
ISO 22716:2007(E) 32

FINISHED PRODUCTS
 Finished products should meet the defined acceptance criteria. Storage, shipment and returns
should be managed in a manner so as to maintain the quality of finished products.
 Prior to being placed on the market, all finished products should be controlled in accordance with
established test methods and should comply with acceptance criteria.
 Product release should be carried out by the authorized personnel responsible for quality.
 Finished products should be stored in defined areas under appropriate conditions for an
appropriate length of time. If necessary, finished products should be monitored while stored.
ISO 22716:2007(E) 33

 Identification of finished product containers should indicate:
a) name or identifying code;
b) batch number;
c) storage conditions when such information is critical to assure the quality of the product;
d) quantity.
 Measures should be taken to ensure the shipment of the defined finished product. Precautions
should be taken to maintain the finished product quality, when appropriate.
ISO 22716:2007(E) 34

QUALITY CONTROL LABORATORY
 Principles described for personnel, premises, equipment, subcontracting, and documentation should
apply to the quality control laboratory.
 The quality control laboratory is responsible for ensuring that the necessary and relevant controls,
within its activity, are carried out for sampling and testing so that materials are released for use and
products are released for shipment, only if their quality fulfils the required acceptance criteria.
 The quality control laboratory should use all test methods necessary to confirm that the product
complies with acceptance criteria.
 Acceptance criteria should be established to specify the requirements to be met for raw materials,
packaging materials, bulk products and finished products.
ISO 22716:2007(E) 35

 All results should be reviewed. After this review, a decision should be made, notably in terms of
approval, rejection or pending.
 Out-of-specification results should be reviewed by authorized personnel and properly investigated.
 There should be sufficient justification for any re-testing to be performed.
 After the investigation, a decision by authorized personnel should be made, notably in terms of
deviation, rejection or pending.
 Sampling should be performed by authorized personnel.
ISO 22716:2007(E) 36

WASTES
 Wastes should be disposed of in a timely and sanitary manner.
 The company should define the different types of waste (from production and from the quality control
laboratory) that could affect the quality of the product.
 The flow of waste should not impact on the production and laboratory operations.
 Appropriate measures should be taken concerning collection, transportation, storage and disposal of
wastes.
 Containers of waste should be properly identified as to contents and other information, as appropriate.
 The disposal of waste should be performed in an appropriate way with an adequate level of control.
ISO 22716:2007(E) 37

INTERNAL AUDIT
 An internal audit is a tool which is designed to monitor the implementation and the status of these
cosmetic Good Manufacturing Practices and, if necessary, to propose corrective actions.
 Specially designated competent personnel should conduct internal audits in an independent and detailed
manner, regularly or on demand.
 All observations made during the internal audit should be evaluated and shared with appropriate
management.
ISO 22716:2007(E) 38

DOCUMENTATION
 Each company should establish, design, install and maintain its own system of documentation that is
appropriate to its organizational structure and to the type of products. An electronic system can be used
to prepare and manage documents
 Documentation is an integral part of Good Manufacturing Practices. Therefore, the objective of
documentation is to describe activities defined in these guidelines in order to relate the history of these
activities and to prevent risks of interpretation, loss of information, confusion or errors inherent to
verbal
 communication.
 Documents should be composed of constituents such as procedures, instructions, specifications,
protocols, reports, methods, and records appropriate to the activities covered by these guidelines.
 Documents can be hard-copy papers or electronic data processing records.
ISO 22716:2007(E) 39

Documents should be:
a) written in a legible and comprehensive way;
b) approved, signed and dated by authorized persons before being used;
c) prepared, updated, withdrawn, distributed, classified;
d) referenced to ensure that obsolete documents are not used;
e) accessible to appropriate personnel;
f) removed from the job area and destroyed if they are out-dated.
Records which require the entry of handwritten data should:
a) indicate what is to be entered;
b) be written legibly with permanent ink;
c) be signed and dated;
d) be corrected, if needed, leaving the original entry still readable; where appropriate, the reason for the
correction should be recorded.
ISO 22716:2007(E) 40

REFERENCE
 http://ec.europa.eu/growth/sectors/cosmetics/
 https://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/
 https://ec.europa.eu/growth/sectors/cosmetics/cpnp_en
 http://www.cosmeticexportpro.com/single-post/2012/06/11/European-Cosmetic-Import-
Regulations
 https://ec.europa.eu/growth/sectors/cosmetics/legislation_en
 ISO 22716:2007(E)
 COLIPA GUIDELINESS ON COSMETIC PRODUCT LABELLING 2011
41

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