Cosmetic Regulation

Table of Contents


Scope

According to the Cosmetics Regulation:

“Cosmetic product means any substance or mixture intended to be placed in contact with external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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.” (Art. 2, p.1a) Cosmetic products shall be safe for human health, when “under normal or reasonably foreseeable conditions of use” (Preamble, p.9).

Site of application:
(✓)  External parts of the human body
(✓)  Mouth

Not applicable:
(✗) Products intended to be placed inside ears, nose, vagina
(✗) Products injected

EC 1223/2009 Recital 2: “products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics”.

Intended main function:
(✓)  Cleaning, perfuming, changing appearance, correcting body odours, protecting, keeping in good condition.

Not applicable:
(✗) Repellents (mosquitoes, lice)
(✗) Soaps with primary biocide function
(✗) Products for muscles, joints

The main function is exerted on the specified application sites: “with a view… to cleaning them, perfuming them, changing their appearance, protecting them or keeping them in good condition”.

Classification

In order to ensure that a product is indeed a cosmetic product, the product formulation, characteristics as well as the sites of application and intended functions need to match the definition of a cosmetic product as defined in the Scope of the EC 1223/2009.

Once the product has been found to match the definition of a cosmetic product, the cosmetic product categories listed in the regulation 1223/2009/EC preamble 7 need to be considered.


Cosmetic Regulation EC 1223/2009

On the 30th of November 2009, the new European Cosmetics Regulation, EC 1223/2009, was published in the official journal of the European Commission,The regulation came into full force on July 11th, 2013, completing replacing the previous law the Cosmetics Directive76/768/EEC.

The general objectives of this New Regulation are to cover the ubiquitous gaps from the previous Directive, which lead to the several amendments in the past, and to once again, harmonize the European Market.

A regulation, by definition, does not allow transposition into national legislations. As a consequence, a regulation has the power of superseding all national laws, preventing Member States from adjusting or adapting regulations for their own purposes. Hence, the main achievement coming with the Cosmetics Regulation 1223/2009/EC is bringing the EU cosmetics market to even greater uniformity.

The Cosmetics Regulation 1223/2009/EC aims, same as the Cosmetics Directive 76/768/EECdid, at the free movement of cosmetic products within the EEA market but also and as important at ensuring the safety of the users of cosmetic products in Europe. Cosmetics free to circulate within the market must acquire evidence to their conformity with the stipulated requirements in their respective Product Information File.

The novelty comes from assigning a greater responsibility to the EU Responsible Person (RP) by clearly indicating that cosmetic products may be placed on the EU market only if an EUResponsible Person (RP) has been designated towards them;

“Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.1).

Furthermore, the regulation brings a new centralized pre-market notification system. This implies that national notifications will not be completed anymore but instead the notification will be electronical towards the European Commission Cosmetic Products Notifications Portal (CPNP). Once a product will be notified by the RP to the CPNP, the product may circulate in all EU Member States.

The Responsible Person is to ensure compliance with the relevant obligations set out in the Regulation: Safety, Good Manufacturing Practices (GMP), Product Information File (PIF), Composition-Restricted Substances, Nano-Materials, Labelling, Claims, Serious Undesirable Effects (SUE), Animal Testing and EU Pre-Market Notifications of Cosmetic Products;

“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).

Path to EU Market Entry: Compliance

To ascertain a better functioning of the European cosmetics market and a higher level of user safety, the New Regulation establishes a set of rules to be fulfilled by every cosmetic product to be placed on the EU market. Compliancy with these set of rules is mandatory for legally placing cosmetic products on the EU market.

The steps to be undertaken in order to ensure the compliance with the Cosmetics Regulation1223/2009/EC can be summarized as follows:

Compliance

EU Responsible Person

As clearly indicated by the EC 1223/2009, designating a Responsible Person is a mandatory requirement.

“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).

The RP is responsible to ensure that all the obligations related to product conformity have been carried out prior to placing the product onto the European Market and then to act as the Cosmeto-Vigilance contact point in Europe towards the cosmetic product he is responsible for.

In supporting any brand owners in gaining EU Compliance, a professional EU Responsible Person should act as a consultant providing:

  • Formula validation - review for restricted, prohibited ingredients, etc.
  • Support collecting, verifying and compiling documentation required for the Product Information File
  • Creation and validation of the Product Information File
  • Review & validation of existing Safety Testing
  • Identification of missing Safety Testing & EU Accepted Protocols
  • Guidance on labeling and language requirements
  • Advice on acceptable claims & proper substantiation
  • Issuing of declarations- No Animal Testing, EU Labeling, Self-Declaring GMP, etc.
  • Pre-Market Notification

Once products have been properly registered (Notified), the EU Responsible Person should also provide:

  • EU Market Strategy
  • Ongoing Regulatory updates & EU Market Consultancy
  • Post-Marketing Surveillance: reporting of Serious Undesirable Effects (SUE), support regarding any EU Competent Authority requests, corrective measures,
  • Immediate corrective measures, withdrawal/recall if appropriate in case of non-conformities.
  • Immediate information to competent authorities (CA) and other economic operators in case of risk to protection of human health.
  • Provide information and documentation to demonstrate conformity as per requests by competent & national authorities. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.

Product Information File

The Product Information File (PIF) is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the EU market. According to the EU Cosmetics Regulation 1223/2009/EC, the elements of the PIF include but are not limited to:

  • Product Description
  • Safety Report:
  • Part A: Cosmetic Product Safety Information
  • Part B: Cosmetic Product Safety Assessment Report
  • Method of Manufacturing
  • Evidence of compliance with Good Manufacturing Practices (GMP)
  • Proof of the effect claimed (where justified)
  • Data on Animal Testing
  • Labeling (taking into account the container and outer packaging)
  • Data on Serious Undesirable Effects
  • And more…

The PIF is kept by the Responsible Person at the address specified on the label (must indicate its address within the European Community) for 10 years after the last batch was put on the market. The PIF should be held in a safe storage location, readily accessible to the Competent Authorities in electronic or other format.

The RP must ensure that the PIF comprehends all the necessary documentation to meet the requirements set by Regulation 1223/2009. It also a task of the RP to ensure compliancy of artwork and claims on the packaging and that the language of the PIF is easily understood by the Competent Authorities, updating the documentation within the PIF when necessary.

It is fundamental for manufacturers to appoint an RP before starting the compilation of the PIF. Appointing an RP in an early phase of the CPNP Notification procedure will guarantee the maximum level of compliance and ensuring that products will successfully undergo a Safety Assessment.

In addition to the standard PIF review, Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will be glad to provide support also in the PIF compilation and Safety Assessor selection.


Good Manufacturing Practices: Ensuring Quality & Consistency

Evidence on Good Manufacturing Practices (GMP) is one of the essential elements when building the Product Information File of a cosmetic product. The Good Manufacturing Practices were created in order to ensure that the manufacturing method is in alignment with the health requirements.

The GMP is only in reference to the entity which actually produces the product (the producer). However, any entity placing cosmetic products onto the EU market under its name is required to have evidence of GMP (in reference to its different producers) as part of their Product Information File (PIF).

Evidence on Good Manufacturing Practices (GMP) can be obtained through:

  • Self declaration by the producer(s)
  • A third-party certificate in reference to an on-site audit


Either method must indicate the chosen criteria of the Good Manufacturing Practices. There are different criteria which can be adopted in case of Good Manufacturing Practices:

  • Colipa Cosmetic Good Manufacturing Practices
  • Council of Europe: Guidelines for good manufacturing practice of cosmetic products
  • CEN/ISO norm 22716


European regulation directs that the CEN/ISO Norm 22716 serves as presumption of conformity towards GMP.


Cosmetic Product Safety Report (CPSR)

The Safety Report, identified in the Annex I of the EC 1223/2009, is one of the essential elements when building the Product Information File of a cosmetic product.

The Safety Report always includes two parts:

Part A: Safety Information

The Safety Information, identified in the Annex I of the Regulation, is Part A of the Safety Report within the Product Information File of a cosmetic product.

The Safety Information includes but is not limited to:

  • The quantitative and qualitative composition of the cosmetic product;
  • The physic-chemical characteristics, microbiological specifications and stability of the cosmetic product;
  • The physic-chemical characteristics, microbiological and toxicological specifications of the raw materials;
  • The impurities, traces, information about the packaging material;
  • Normal and reasonably foreseeable use of the cosmetic product;
  • Exposure to the cosmetic product and substances;
  • Undesirable effects and serious undesirable effects

The safety information can be obtained through the suppliers of the raw materials and the producers of the finished product (easily accessible when producing according to Good Manufacturing Practices) or with the support of external testing laboratories.

Part B: EU Safety Assessment

The Safety Assessment, identified in the Annex I of the Regulation, is Part B of the Safety Report within the Product Information File of a cosmetic product. The Safety Assessment includes but is not limited to:

  • Statement on the safety of the cosmetic product in relation to Article 3;
  • Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1) (d);
  • Explanation of the scientific reasoning leading to the assessment conclusion which is to be based on the possible interactions of the substances contained in the cosmetic product and also on the Safety Information documentation;
  • Justification of the consideration and non-consideration of the raw materials’ toxicological profiles;
  • Consideration of the impact of the stability on the safety of the cosmetic product;
  • Assessor’s credentials and approval (name and address, proof of qualification, date and signature).

The safety assessment is to be completed by a qualified person with a European degree in pharmacy, medicine, toxicology or a related discipline otherwise known as a “Safety Assessor”. When the qualification degree diploma is not obtained from a European University, the Safety Assessor must have it recognized by the appointed national bodies within one of the EU Member States.

A special safety assessment needs to be issued in case the products are:

  • Intended for use on children under 3 years old.
  • Intended exclusively for use in external intimate hygiene.

Mandatory Safety Testing

The new Cosmetics Regulation EC 1223/2009 clarifies requirements for safety of a cosmetic product and includes clearer requirements for manufacturers to compile the Product Information File prior to placing a cosmetics product on the European market.

Part of the requirements of EC 1223/2009 are listed in the Safety Report (which includes the Safety Information & Safety Assessment). Among these requirements are the safety tests. The main safety tests are listed below:

Stability Test:

  • General Considerations
  • Test Method
  • Acceptance Criteria
  • Conclusion Report

Read more: Stability Tests

Compatibility Test:

  • General Considerations
  • Test Method
  • Acceptance Criteria
  • Conclusion Report

Read more: Compatibility Tests

Challenge Test:

  • General Considerations
  • Test Method
  • Acceptance Criteria
  • Conclusion Report


Read more: Challenge Tests


EU Labeling

img_EU-Label

The final artwork of a cosmetic product labeling, must follow certain rules – click here to review the EU Labeling rules.

The final artwork of a cosmetic product labeling, must follow certain language requirements –click here to review the EU language requirements.

Disclaimer!

This label example is only for general information and cannot be applied automatically to any product. Only once the EU compliance process has been completed (including the safety tests, safety assessment, PIF & Notification) will a product’s label be validated and be correct in reference to the specifics of the product.


Cosmetic Product Notification Portal (CPNP)

Pre-Market Notification

One of the main requirements of the Regulation EC 1223/2009, transposed from the previous cosmetics law, is the pre-market notification.

The Notification can only be completed by the designated Responsible Person and only AFTER the Product Information File encloses all evidence of conformity.

The Notification of a Cosmetic product indicates that:

A cosmetic product notified in the CPNP – one time notification, may be placed on any of the EU markets provided that the labeling is in conformity with the language requirements of the respective country. As such, no national notifications are necessary anymore.

The information to be submitted to the CPNP includes but is not limited to:

  • Product category + name(s) enabling specific identification
  • Name and Address of the Responsible Person where the PIF is made readily accessible
  • Country of origin (for imported products)
  • First Member State where the product will be first placed on the market.
  • Presence of Nano-Materials
  • Presence of CMR 1A/1B substances
  • Frame formulation
  • Labeling

At the completion of the Notification procedure, each product is assigned a CPNP reference code.

Notification When Changing EU Responsible Person

Each product Notification (and corresponding CPNP #) is tied to the EU RP which verified the compliance. If, at a later date, a brand owner elects to change EU Responsible Persons, the products must be de-Notified by the previous EU Responsible Person and re-Notified upon the due diligence activities of the newly appointed EU Responsible Person. The previous EU Responsible Person information must also be removed from the packaging. Any future inquiries related to the product compliance will be forwarded to the newly appointed EU RP.


Nanomaterials

Information about the compliance with the new Regulation 1223/2009/EC of nanomaterials used in cosmetic products is covered in article 16.

Nanomaterials are insoluble or bio-persistent particles intentionally manufactured. The dimension of 1 nanomaterial particle is smaller than 100nm.

Nanomaterials that are not present in the Annexes IV, V and VI, of the new Regulation1223/2009/EC, must be notified to the CPNP.

This notification is to be completed by the Responsible Person 6 months prior placing the finished cosmetic product on the market. The CPNP (Cosmetic Products Notifications Portal) of the European Commission supports the notification of nanomaterials as well.

The European Commission has indicated that they will be publishing the nanomaterials catalogue which will be listing the nanomaterials for which the safety concerns were assessed and as such these specific nanomaterials will not need to be notified anymore.

The presence of nanomaterials in a cosmetic product must be indicated in the product’s labeling information.

Products containing nanomaterials may be placed on the market 6 months after the notification of their nanomaterials ingredients to the CPNP and as any other cosmetic product, after its own notification to the CPNP.

The European Commission engaged to issue the Nanomaterials Catalogue listing the nanomaterials for which sufficient safety information was gathered revoking as such the need for their notification.


Post-Market Surveillance

It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves.

Manufacturers should keep their EU Responsible Person apprised of any changes in formulation, claims, product names or any other matters that could potentially impact the compliance of their product.

As consumers use the products, any undesirable or serious undesirable effects (SUE)  reported by end-users should also be recorded within the respective Product Information File (PIF) and, depending on the circumstances, reported to the Competent Authorities.

When a manufacturer becomes aware of non-compliant product entering the market, non-compliant batches, etc. they should take action immediately to resolve the situation.


Failure to Comply: Risks of Non-Compliance

Evidently, non-compliant products enter the EU Market everyday - whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.

As there is no "approval" in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.

Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.

The main consequences include, but are not limited to:

  • Being publicly reported to the RAPEX
  • Warehousing Fees
  • Requested Withdrawal
  • Mandated Withdrawal
  • Product Recall (from end-users and/or the market)
  • Complete ban on marketing of the product
  • Destruction of the product
  • Fines

Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed EU Responsible Person. Above all else, the professionalism and expertise of the appointed EU Responsible Person in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.


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