The responsibilities of the responsible person regarding manufacturing or importing cosmetic products

Cosmetic products knowledge base – The responsibilities of the responsible person

According to Regulation (EC) No 1223/2009, we can distinguish two main participants whose obligations and responsibilities are different, this is why at first it is extremely significant to determine into which category our company belongs to.

Responsible person

For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.

For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.  The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.

If the distributor places a cosmetic product on the market under his name or trademarkor modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected, the distri shall be the responsible person.

The responsible person might be:

• the manufacturer (if established within the European Union)
• the importer (if the product manufacturer is established outside the European Union)
• the distributor (if they place the product on the market under their own brand name)
• appointed person or company (who is named by the manufacturer or the importer and who shell accept in writing)

The responsible person is obliged to ensure that the cosmetic product meets the requirements of Regulation (EC) No 1223/2009.

According to the regulation, a cosmetic product can only be distributed if it has a

• Safety Assessment and Safety Report
• Product Information File (PIF)
• appropriate labelling
• and its manufacturing is made according to the guidance of ISO 22716 and complies with good manufacturing practise (GMP)

Creation of Safety Assessment and Safety Report

The safety assessment and the safety report based on it intended to prove that cosmetic products are safe for human health when used under normal or reasonably foreseeable conditions of use.

The responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment and that a cosmetic product safety report is set up, and it is updated in case any further relevant information is received after starting the distribution.

The Safety Assessment of the cosmetic product is an essential part of the Product Information File (PIF) needed for the distribution of the cosmetic product.

Compilation of Product Information File

Compilation of a Product Information File complying with Regulation (EC) No 1223/2009 is the criterium of the distribution and EU notification of cosmetic products (cosmetics).

The Product Information File (PIF) shall contain the following information:

• a description of the cosmetic product
• the safety report
• description of the method of manufacturing
• a statement on compliance with good manufacturing practice (GMP)
• proof of the effect claimed for the cosmetic product, where justified  by the nature or the effect of the product
• data on any animal testing relating to the development or safety assessment of the cosmetic product or its ingredients

The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the PIF shall be available in a language which can be easily understood by the competent authorities of the Member State.

The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

Label elements

Cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:

1. The name or registered name and the address of the responsible person. The country of origin shall be specified for imported cosmetic products.

2. The nominal content at the time of packaging, given by weight or by volume

(Exception: pre-packages normally sold as a number of items, for which details of weight or volume are not significant; packaging containing less than five grams or five millilitres; free samples and single-application packs.)

3. Date of minimum durability

a, Indication of the date of minimum durability for cosmetic products with a minimum durability of less than 30 months.

Appropriate format: after the date of minimum durability symbol or the words “best used before the end of” the date of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order.

b, in case of cosmetic products with a minimum durability of more than 30 months, there shall be an indication of the period of time after opening for which the product is safe and can be used without any harm to the consumer.  The minimum durability symbol is followed by the time indicated in months and/or years, except where the concept of durability after opening is not relevant: for single-use products, products not at risk of deterioration or products which do not open.

4. Particular precautions to be observed in use.

5. The batch number of manufacture or the reference for identifying the cosmetic product.

6. The function of the cosmetic product, unless it is clear from its presentation

7. List of ingredients according to INCI (International Nomenclature Cosmetic Ingredient). This information shall be indicated only on the outer packaging (if applicable).

The labeling information must be provided in the language of the Member State where the product is distributed for the end user (except: “Ingredients”).

If it is not possible to indicate the listed information on the label due to practical reasons, the information must be indicated on a leaflet, label, tape or card enclosed or attached to the product.

Notification of a cosmetic product

Before starting the distribution, the responsible person is obliged to report electronically the following information regarding the cosmetic product via CPNP:

• the category of the product and its name and/or specific identificator,
• the name and address of the responsible person where the product information file is made readily accessible
• the country of origin,
• the Member States in which the cosmetic product is to be placed on the market,
• the contact details of a physical person to contact in the case of necessity,
• the presence of substances in the form of nanomaterials and their identification including the chemical name  and the reasonably foreseeable exposure conditions,
• the name, CAS number or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR),
• the frame formulation
• the original labelling
• photo of the packaging

When any of the information changes, the responsible person shall provide an update without delay via CPNP.

Related professional materials

• Obligations of distributors of cosmetic products

Offered services

• Our CPNP notification service for cosmetic products
• Our label draft creation and translation service for cosmetic products
• Our Compilation of Safety Assessment service for cosmetic products