Cosmetics and personal care

Not checked: ClaraDB has not checked this type of question, so it does not say whether this law applies to your product. The law and its quote are shown as found. See what ClaraDB has checked

• Corrective measures where a product placed on the market is not in conformity

  “Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.”

• Notify Competent national authorities of the Member States in which the product was made available and of the Member State where the product information file is readily accessible: notification of authorities where the product presents a risk to human health

  “Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States …”

• Manufacture must follow good manufacturing practice

  “The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article …”

• Get a cosmetic product safety report (CPSR) from a qualified safety assessor before the first sale

  “the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”

• Have the safety assessment done by a qualified assessor (a diploma in pharmacy, toxicology, medicine or a similar discipline)

  “shall be carried out by a person in possession of a diploma or other evidence of formal qualifications …”

• Hold a declaration: product information file, kept for ten years after the last batch was placed on the market, containing the product description, the safety report (Art. 10(1)), the manufacturing method and GMP statement, proof of the claimed effect where justified, and animal-testing data (Art. 11(2))

  “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it.”

• Disclose: PIF accessible to authority at address on label, in understandable language

  “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.”

• Notify the product in the EU Cosmetic Products Notification Portal (CPNP) before placing it on the market

  “Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission: …”

• Add the original label, and a photo of the packaging where legible, to the CPNP notification

  “the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging …”

• Notify European Commission (CPNP): update of notified information when it changes

  “Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.”

• Disclose: public access to composition and undesirable effect data

  “the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects …”

• Notify Competent authority of the Member State where the serious undesirable effect occurred: notify serious undesirable effects

  “In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred: …”

• 2351 more rules found in this law.