Obligations of the responsible person
The responsible person ensures that the cosmetic products they place on the EU/EEA market comply with statutory requirements and are safe for human health.
The responsibilities of the responsible person include
- ensuring that the cosmetic product is safe for human health;
- compliance with restrictions and bans pertaining to substances;
- compliance with the ban on animal testing;
- compliance with Good Manufacturing Practice (GMP);
- ensuring that a safety report is prepared;
- verifying the competence of the safety inspector;
- ensuring accuracy of product labelling;
- submitting a notification on the product to the CPNP portal and updating notifications when necessary;
- maintaining and updating product information;
- identifying the supply chain upon request by an authority;
- taking measures if it suspects that a product it has imported/manufactured is not compliant with requirements, in practice this means taking necessary corrective measures, recalling the product from the market or removing the product from end users;
- collaboration with authorities when requested by an authority;
- notifying authorities if a cosmetic product poses a danger to human health;
- demonstrating upon request by an authority that a cosmetic product is compliant with statutory requirements;
- notifying an authority of any products that have caused serious undesirable effects, notifications on cases that have occurred in Finland should be submitted to Tukes.
Safety assessment and safety report
The responsible person must ensure that the safety of the cosmetic product has been assessed and that a cosmetic product safety report is drawn up before the product is placed on the market.
A safety report consists of two parts: a cosmetic product safety report and a safety assessment.
The responsible person is responsible for ensuring that the party who carries out the safety assessment has sufficient qualifications, such as higher education decree including theoretical and practical studies in pharmacy, toxicology, medicine or another similar field.
Communication of serious undesirable effects
If the responsible person becomes aware of a serious undesirable effect of a cosmetic product the responsible person must immediately notify Tukes.
The responsible person must report serious undesirable effects that have occurred in a country other than Finland to the competent authority responsible for enforcement of cosmetics legislation in the Member State in which the serious undesirable effect occurred.
The responsible person is responsible for maintaining the product information of the cosmetic product.
Product information must include:
- A safety report
- A detailed description of the cosmetic product
- A statement about Good Manufacturing Practices
- Proof of alleged effects
- Information on all animal testing involved.
The responsible person must keep the product information for ten years, starting from the day the last cosmetic product batch was placed on the market. For example, if the last batch of the product was placed on the market on 1 January 2011, the product information must be kept for 10 years from this date. Product information must be kept up to date. Labelling of cosmetic products must indicate the street address where authorities can access the product information. The company’s web address is not enough.
Good manufacturing practice
The responsible person must make sure that cosmetic products are manufactured in accordance with Good Manufacturing Practice (GMP).
Standard SFS-EN ISO 22716 deals with good manufacturing practices related to cosmetics. The standard for example gives guidelines for the production, control, storage and delivery of cosmetic products. The standard covers the following quality aspects: personnel, premises and equipment, raw materials and packaging materials, production, finished products and quality control.
Cosmetic products notification portal, CPNP
Before a cosmetic product is placed on the EU/EEA market the responsible person must submit the product to the electronic database maintained by the European Commission, the Cosmetic Product Notification Portal (CPNP).
The responsible person must submit the following information to the CPN portal:
- product group of the cosmetic product and trade name or names that can be used to identify the product;
- name of the responsible person and the street address where the product information is kept available;
- the product’s country of origin if the product is imported from outside the EU/EEA;
- the EU/EEA Member State where the product is placed on the market;
- name of the person who can be contacted if needed;
- nanomaterials contained in the product;
- names of substances, including chemical name (IUPAC) and other descriptors, such as INN, CAS number, EC number or XAN name or INCI name accepted by certain countries;
- exposure conditions which may reasonable be foreseen;
- CAS or EC number of category 1A and 1B CRM substances pursuant to Part 3 of Annex VI of the CLP Regulation (EC No 1272/2008); and
- frame formulation, which helps provide quick and appropriate treatment if problems occur.