The Cosmetics Regulation

On the 30th of November 2009, the 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, completely replacing the previous law the Cosmetics Directive 76/768/EEC.

The general objectives of this Regulation are to cover the ubiquitous gaps from the previous Directive, which lead to the several amendments in the past, and to 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).

Scope

According to the Cosmetics Regulation, a “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 odors.” (Art. 2, p.1a) Cosmetic products shall be safe for human health, “under normal or reasonably foreseeable conditions of use” (Preamble).

Site of application:

• External parts of the human body
• Oral cavities

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, claims 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.

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 during the manufacturing process health requirements are taken in consideration.

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

Information about the compliance with the Regulation 1223/2009/EC requirements related to 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 Regulation 1223/2009/EC, must be notified to the CPNP. The CPNP (Cosmetic Products Notifications Portal) of the European Commission supports the notification of nanomaterials as well.

Cosmetic products containing nanomaterials shall be notified to the Com­mission by the responsible person by electronic means six months prior to being placed on the market […] (art. 16.3).

The presence of nanomaterials in a cosmetic product must be indicated in the product’s labelling information by adding “nano” after each ingredient falling under this category.

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

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

Manufacturers must keep their EU Responsible Person informed 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), revised within the Safety Assessment report if needed and, depending on the  circumstances, reported to the Competent Authorities.

When a manufacturer becomes aware of a non-compliant product entering the market, non-compliant batches, etc. They along with the Responsible Person must take action immediately to resolve the situation.

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

As there is no “pre-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 shelves, stopping products at customs or even deploying online checks to identify EU or non-EU based e-commerce shops which mention that they ship to the EU Market.

Should you choose to take the risk to ship cosmetic products to Europe which have 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 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, the  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.