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FAQ regulamento cosmético na União Europeia e Reino Unido

EU and UK Cosmetic Regulation

FAQ

  • Every product placed on EU and UK markets must have a product information file (PIF) compiled. The PIF is a set of various documents and tests related to the finished product, raw materials, packaging specifications, manufacturing process, etc. The content of the PIF is described in Article 11 of the EU Cosmetic Products Regulation, where it is written that the PIF must contain the following information and data:

    A description of the cosmetic product that allows the product information file to be clearly attributed to the cosmetic product

    The cosmetic product safety report referred to in paragraph 1 of article 10.

    A description of the manufacturing method and a declaration of compliance with good manufacturing practice referred to in Article 8.

    Where the nature or effect of the cosmetic product justifies it, proof of the effect claimed for the cosmetic product

    Data on animal testing carried out by the manufacturer, its agents or its suppliers in connection with the development or safety assessment of cosmetic products or their ingredients, including any animal testing carried out to comply with country legislative or regulatory requirements the 3rd.

    The product information file must be maintained by the responsible person, at a single address in the EU (which must be specified on the label), readily accessible to the competent authority of the Member State where the responsible person maintains the PIF, even for 10 years after the last batch of the product was placed on the market.

    The documents contained in the BIP must be written in a language that is easily understandable by the competent authority of the Member State where the BIP is stored.

  • To ensure the safety of cosmetic products placed on EU and UK markets, cosmetic products must be produced in accordance with good manufacturing practice (GMP).

    There are several GMP standards, but the applicable standard in the EU is ISO 22716. This standard provides guidance for the production, control, storage and dispatch of cosmetic products and affects manufacturers, as well as suppliers, retailers, brand holders and cosmetic product retailers.

  • CPNP is the acronym for Cosmetic Products Notification Portal. This is an EU online notification system where responsible persons submit certain information about the cosmetic products they place or make available on the EU market. This information is then made available to competent authorities and poison centers in EU Member States.

  • SCPN stands for Submit Cosmetic Product Notifications. This is a Great Britain (GB) online notification system in which responsible persons submit certain information about the cosmetic products they place or make available on the GB market. This portal is managed by the Office for Product Safety and Standards (OPSS).

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