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Cosmetics Regulation

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in Cosmetics Regulation
| The Regulation: EC 1223/2009 | Scope | Compliance Product ClassificationProduct Information File (PIF)Good Manufacturing Practices (GMP)Cosmetic Product Safety Report (CPSR)Safety Tests – EC 1223/2009EU LabelingEU NotificationNanomaterials |

The Regulation: EC 1223/2009

in Cosmetics Regulation

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 Directive 76/768/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/EEC did, 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 EU Responsible 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).

 


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Scope

in 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”.


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Compliance

in Cosmetics Regulation

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 Regulation 1223/2009/EC can be summarized as follows:

Compliance


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Product Classification

in Cosmetics Regulation

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.


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Product Information File (PIF)

in Cosmetics Regulation

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 language of the PIF is easily understood by the Competent Authorities and updates the documentation within the PIF when necessary.


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Good Manufacturing Practices (GMP)

in Cosmetics Regulation

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.


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Cosmetic Product Safety Report (CPSR)

in Cosmetics Regulation

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:

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.

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.

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Safety Tests – EC 1223/2009

in Cosmetics Regulation

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

Safety Assessment:


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EU Labeling

in Cosmetics Regulation

img_EU-Label

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

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.


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EU Notification

in Cosmetics Regulation

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:

  • The product is ready from a compliance points of view to be placed on the European market.

 

The notification to the European Commission centralized database – the Cosmetic Products Notifications Portal (CPNP) is a new element brought by the new Regulation. The portal became accessible to its users (Responsible Persons, distributors, Competent Authorities and Anti-Poison Centers) since January 11th, 2012.

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
  • 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

 

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.

Application dates for Notification to the CPNP (Cosmetic Product Notification Portal):

 

  Already on the market New products
Notification of products January 11th, 2012 and no later than  July 11th, 2013 Prior to placing on the market
Notification of products with Nano-Materials January 11th, 2013 and no later than  July 11th, 2013 6 months before placing on the market

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Nanomaterials

in Cosmetics Regulation

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 Regulation 1223/2009/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.


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