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Legislation And Regulations For Import,
Manufacture, Distribution And Sale of
Cosmetics In European Union
1
Guided by:
Dr. Zanza Patel
Assistant professor of
Parul Institute of
pharmacy
Prepared by:
Charmi Shah
(2308212170009)
M. pharm 2nd sem
FACULTY OF PHARMACY
PARUL INSTITUTE OF PHARMACY
LIMDA, VADODARA
CONTENTS:
EU’S Role in cosmetics
Import of Cosmetics
Specific guidance for each labelling requirement
GMP for cosmetics in EU
Distribution of cosmetic in EU
References
2
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.
3
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 odors."
4
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.
5
Marketing of products requires:
• Informing the European Commission of products. This process is made possible
by the New European Cosmetic 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.
6
Specific Guidance For Each Labelling
Requirement(Sale of cosmetics)
1) Name and address of responsible person
Country of origin 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.
Importer
Third party with a written mandate from the manufacturer or the importer.
7
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
portal 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 milliliters, and others)
• According to Directive 76/211/EC the nominal quantity (nominal weight or nominal
volume) is expressed in kilograms, grams, liters, centiliters or milliliters.
8
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
 date of minimum durability shall be clearly expressed and preceded by the mention
"best used before the end of"
 The date consists either of the month and year (MMYYYY or MMYY) or the day,
month and year (DMMYYYY or DDMMYY), in that order. 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.
9
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
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.
 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.
10
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.
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.
11
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.
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 .
The common name for ingredient labelling referred to in the EU regulation is
known as the International Nomenclature Cosmetic Ingredient name or INCI name
12
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.
13
1. PERSONNEL HYGIENE AND HEALTH
 Hygiene programmed 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 if 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.
14
2. 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.
15
3. 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
16
17
4. 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:
• name of the product marked on the delivery note:
• name of the product as given by the company, if different from the name given by
the supplier and/or its code number;
• date or number of receipt, if appropriate:
• supplier's name:
• batch reference given by the supplier and the one given at receipt, if different.
5. 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:
• suitable equipment:
• formula for the product:
• list of all raw materials identified according to relevant documents indicating batch
numbers and quantities;
• 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.
18
19
6.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.
7. 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.
20
21
8.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.
DISTRIBUTION OF COSMETICS
Cosmetics in Europe are distributed through a network of channels, reaching
consumers in a variety of ways. Here's a breakdown of the main distribution channels
for cosmetics in Europe:
1. Selective Distribution: This channel involves selling cosmetics through a limited
number of authorized retailers, such as high-end department stores, perfumeries,
and specialty beauty stores. Selective distribution is often used for luxury and
prestige cosmetics brands, where the focus is on brand image and customer
service.
22
23
2. Mass Market Distribution: This channel involves selling cosmetics at lower
prices through a wider variety of stores, like supermarkets, drugstores, and
discount stores. These stores typically carry a broader selection of personal care
products alongside the cosmetics.
3.Direct Sales: This channel involves selling cosmetics directly to consumers
through a network of independent sales representatives. Direct sales are a
popular channel for some cosmetics brands, as it allows for a more personalized
sales approach.
4. Online Sales: Online sales of cosmetics have grown significantly in recent
years. Consumers can now purchase cosmetics directly from brand websites, as
well as from online retailers.
REFERENCES:
• https://singlemarketeconomy.ec.europa.eu/sectors/cosmetics/legislation_en
• https://single-market-economy.ec.europa.eu/sectors/cosmetics/market-
surveillance_en
• ISO:22716: 2007(E)
24
THANK YOU!
25

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Legislation And Regulations For Import, Manufacture,.pptx

  • 1. Legislation And Regulations For Import, Manufacture, Distribution And Sale of Cosmetics In European Union 1 Guided by: Dr. Zanza Patel Assistant professor of Parul Institute of pharmacy Prepared by: Charmi Shah (2308212170009) M. pharm 2nd sem FACULTY OF PHARMACY PARUL INSTITUTE OF PHARMACY LIMDA, VADODARA
  • 2. CONTENTS: EU’S Role in cosmetics Import of Cosmetics Specific guidance for each labelling requirement GMP for cosmetics in EU Distribution of cosmetic in EU References 2
  • 3. 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. 3
  • 4. 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 odors." 4
  • 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. 5
  • 6. Marketing of products requires: • Informing the European Commission of products. This process is made possible by the New European Cosmetic 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. 6
  • 7. Specific Guidance For Each Labelling Requirement(Sale of cosmetics) 1) Name and address of responsible person Country of origin 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. Importer Third party with a written mandate from the manufacturer or the importer. 7
  • 8. 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 portal 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 milliliters, and others) • According to Directive 76/211/EC the nominal quantity (nominal weight or nominal volume) is expressed in kilograms, grams, liters, centiliters or milliliters. 8
  • 9. 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  date of minimum durability shall be clearly expressed and preceded by the mention "best used before the end of"  The date consists either of the month and year (MMYYYY or MMYY) or the day, month and year (DMMYYYY or DDMMYY), in that order. 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. 9
  • 10. 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 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.  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. 10
  • 11. 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. 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. 11
  • 12. 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. 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 . The common name for ingredient labelling referred to in the EU regulation is known as the International Nomenclature Cosmetic Ingredient name or INCI name 12
  • 13. 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. 13
  • 14. 1. PERSONNEL HYGIENE AND HEALTH  Hygiene programmed 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 if 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. 14
  • 15. 2. 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. 15
  • 16. 3. 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 16
  • 17. 17 4. 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: • name of the product marked on the delivery note: • name of the product as given by the company, if different from the name given by the supplier and/or its code number; • date or number of receipt, if appropriate: • supplier's name: • batch reference given by the supplier and the one given at receipt, if different.
  • 18. 5. 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: • suitable equipment: • formula for the product: • list of all raw materials identified according to relevant documents indicating batch numbers and quantities; • 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. 18
  • 19. 19 6.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.
  • 20. 7. 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. 20
  • 21. 21 8.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.
  • 22. DISTRIBUTION OF COSMETICS Cosmetics in Europe are distributed through a network of channels, reaching consumers in a variety of ways. Here's a breakdown of the main distribution channels for cosmetics in Europe: 1. Selective Distribution: This channel involves selling cosmetics through a limited number of authorized retailers, such as high-end department stores, perfumeries, and specialty beauty stores. Selective distribution is often used for luxury and prestige cosmetics brands, where the focus is on brand image and customer service. 22
  • 23. 23 2. Mass Market Distribution: This channel involves selling cosmetics at lower prices through a wider variety of stores, like supermarkets, drugstores, and discount stores. These stores typically carry a broader selection of personal care products alongside the cosmetics. 3.Direct Sales: This channel involves selling cosmetics directly to consumers through a network of independent sales representatives. Direct sales are a popular channel for some cosmetics brands, as it allows for a more personalized sales approach. 4. Online Sales: Online sales of cosmetics have grown significantly in recent years. Consumers can now purchase cosmetics directly from brand websites, as well as from online retailers.