As a member of the European Association of Manufacturers and Formulators of Enzyme Products (AMFEP), c-LEcta is actively involved in the enzyme industry’s commitment to ensure the highest safety standards for its products and to facilitate their efficient assessment by the competent authorities worldwide.
For our food enzyme products, we take care of the overall coordination of approval processes, from the generation and/or gathering of all necessary data to the preparation of technical dossiers. We also have experience in the joint coordination of approval submissions together with the involved food manufacturers and/or external consulting companies.
Please contact us at fiapenzymedossiersc-lectacom for questions and regulatory support regarding food enzymes.
EU-based manufacturers and importers of chemicals, which by definition also include enzymes, are required to register chemicals that are manufactured or imported in yearly tonnages exceeding a certain level (REACh; Registration, Evaluation, Authorization, and Restriction of Chemicals). Similar registration systems exist likewise outside the European Union, such as the Toxic Substances Control Act (TSCA) in the USA and the New Chemical Substance Notification in China (China REACh), all aiming at the protection of human health and the environment from the potential risk of chemicals.
As a worldwide operating company, c-LEcta is well aware of international registration obligations, carefully monitors the volume requirements of our products resulting from market needs and trends, implements risk assessments and on-time registrations and ensures fully compliance with the respective regulations.