The Cosmetics Regulation

Since 2013, the EU Regulation 1223/2009/EC regulates cosmetic products in the EU and EEA countries. Full compliance with the EU Cosmetics Regulation allows manufacturers to place their cosmetics in all EU countries as well as Lichtenstein, Norway, and Iceland. After a notification performed by the Responsible Person on the CPNP portal, products are free to circulate in these territories as long as they meet any further national requirements.

Most importantly, the Regulation states that only products having a Responsible Person (RP) within the EU can enter the market. For products made by non-EU manufacturers, the law provides that the importer is automatically the RP, unless it designates another entity.

Moreover, manufacturers can place on the EU market only cosmetics having a compliant Product Information File (PIF). The main elements of a PIF are safety assessment report, formula, raw material documentation, tests, declarations, labels, packaging specifications, finished product specifications, and manufacture method.

The EU Cosmetics Regulation covers cosmetic products which are substance or mixture used on external body parts, such as skin, hair, nails, lips, and external genital organs as well as teeth and mucous membranes of the oral cavity. To be classified as a cosmetic, such products are intended to be used to clean, perfume, change the appearance, protect, keep the mentioned body parts in good conditions or correct the body odours.

Evidence of Good Manufacturing Practices (GMP) is an essential element when building a cosmetic product’s Product Information File (PIF). Good Manufacturing Practices were introduced to ensure that during the manufacturing process, health requirements are taken into consideration.

The GMP only refers to the entity which produces the product (the producer). However, any entity placing cosmetic products on the the EU market under its name must have evidence of GMP (about its different producers) as part of its PIF.

According to the EU Cosmetics Regulation, a nanomaterial in cosmetics is “an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm”. However, its definition is under discussion and might be subject to revision.

Nanomaterials that are not present in the Annexes IV, V and VI, of the Regulation must be notified to the CPNP by the Responsible Person. 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. When the products do not contain nanomaterials, the manufacturer must provide a declaration (from the producer) stating the absence of nanomaterials.

Each brand owner has the responsibility to continue to collect information related to the use of their products after they have been made available to consumers. Moreover, they are responsible to ensure that their products 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 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., along with the Responsible Person, they must immediately resolve the non-compliance.

Non-compliant products enter the EU Market every day – whether the brand owner knowingly acts this way or due to a lack of knowledge imparted by EU importers/distributors.

As there is no “pre-approval” in the EU Market, Competent Authorities focus almost exclusively on conducting systematic surveillance of products on the market. In case of non-conformities, the Competent Authorities can pull products off shelves, stop products at customs, or even deploy online checks to identify EU or non-EU-based e-commerce shops which mention that they ship to the EU.

Should brand owners choose to take the risk of shipping cosmetic products which have not followed the required compliance path, they could face some of the following consequences:

• Being publicly reported to Safety Gate
• Warehousing fees
• Requested withdrawal
• Mandated withdrawal
• Product Recall (from end-users and/or the market)
• A complete product ban
• Destruction of the product
• Fines