European regulations for compounds and products

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

Abstract

Until the 1950th each European country regulated chemical substances differently. The establishment of the European Community legislation has replaced national law for the purpose of harmonization. The national authorities are responsible for implementing EU legislation in national law. Generally, the national competent authorities prepare dossiers to regulate a specific compound or product, present it to the specific European agency or institution, which evaluate the proposal and after approval by the specific authorities of the member states submit the final proposal to the European Commission for final acceptance. The major European Authorities are the European Chemical Agency (ECHA), the European Food Safety Agency (EFSA), the European Medicines Agency (EMA). For cosmetic products the producer has to submit a product information file to the competent authority in the Member State. The safety assessment is evaluated by the Scientific Committee on Consumer Safety (SCCS) of the Directorate-General for Health and Food Safety (SANTE).

Original languageEnglish
Title of host publicationEncyclopedia of Toxicology, Fourth Edition
Subtitle of host publicationVolume 1-9
PublisherElsevier
PagesV4-543-V4-547
Volume4
ISBN (Electronic)9780128243152
DOIs
StatePublished - 1 Jan 2023

Keywords

  • Authorization
  • Chemicals
  • Cosmetics
  • European regulations
  • Evaluation
  • Human and veterinary drugs
  • Pesticides
  • Registration
  • Restriction

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