Avena Consultants are natural product regulatory compliance experts specialising in UK and European Union (EU) nutritional food, supplements, medicines and cosmetic laws. Avena provides tailored services to assist with all your compliance needs. We help get your products compliant and ready for market.
Typical services include: EU legal definition of products; marketing claim reviews; compliant labelling; formula analysis; formulation assistance; guidance on import rules and certificates; and company regulatory requirements such as manufacturing standards and correct licences.
Avena supports a range of manufacturers and distributors from around the world as they launch products into the UK and EU. Sharing our significant experience, we deliver plain English guidance on often complex regulations, and efficient strategies for operations and product launches. If you are looking for regulatory guidance and compliance services for food supplement, herbal medicine and cosmetics products, we can help you.
Avena ensures you know the correct manufacturing standards required for products; for example, HACCP for the European food supplement market or guidance on specific certificates and paperwork needed to get your products through customs.
What is my product? Well it could be a food supplement, food, novel food, medicine, medical device or a traditional herbal medicine. We assess your product and define it in terms of EU law by analysing its form and claimed function. Each type of product type has specific regulatory rules and processes in the UK and EU. Avena Consultants delivers streamlined guidance on laws, regulations, licences, certificates, add-on services and costs.
Avena Consultants ensures food supplement formulas, packaging and promotion is EU compliant. We provide easy to understand reviews of labels and websites against EU nutritional and health claim regulations. There is no official EU-wide list of authorised food (dietary, nutraceutical) supplement substances. Each of the 28 member states has their own opinion on what substances they consider ok to use. Avena Consultants are borderline grey area specialists with significant regulatory and scientific understanding of botanical ingredients.
Avena Consultants can tell you if your products are viable for an EU traditional herbal medicinal product license and complete common technical document (CTD) dossiers for traditional herbal registration (THR) licence applications via the Medicines and Healthcare Regulatory Agency (MHRA) UK.
Avena uses years of experience in regulations and claim law, plus a sound scientific understanding of natural product ingredients to come up with formulations that are effective, safe and have ingredients that you can make authorised claims on. You tell us the preferred form, intended function and claims you wish to make and we do the rest for you.
Avena provide guidance on the relatively new Cosmetics Regulation (EC) n°1223/2009, which came into force July 2013, from correct labelling to company responsibilities, product testing and EU cosmetic safety assessments.