Regulatory Updates

EC Register of Nutrition and Health Claims

The EU Register of Nutrition and Health claims is now accessible. A consolidated list of what has been authorised and non-authorised is a step forward, however small. Mainly the focus for now is on Vitamins and Minerals. Making claims on botanicals, probiotics and amino acids is still a bit of a grey area, some are lobbying for a pending list so they know what is coming up. The authorised claim wording is formal and distinctly non-marketable in copy style.  Avena helps you comply whilst appreciating each company’s own marketing style on the product.

Cosmetics Directive coming into force

The changes to the Cosmetic Directive (76/768/EEC), from new EU regulation (EC) No 1223/2009 will come into force by July 2013. The main changes producers should note are to the cosmetic safety assessments (part of the product information file). These are more complex and the data required for an assessor to carry out the assessment is more rigorous. The upside is there will be a new EU central register, meaning you don’t have to register with each national regulator in your chosen EU markets. The responsibilities of the actors in the supply chain are more clearly defined by this regulation and assigned to a responsible person.

Echinacea, only for grown ups

The MHRA have been actively trying to record adverse reactions in herbals over the past few years, the hunt for data to crunch is on the increase. Due to reports of allergic reactions in children to Echinacea, the MHRA are now state that Echinacea products should not be given to children under 12, although they have not found a serious safety issue and say parents should not worry if they have given Echinacea to children under 12 in the past. This announcement has meant product pulls for companies that have gone through getting them licensed under THR, it also effects unlicensed Echinacea products, parents may be wary of buying them for children now. Whilst many companies and herbal practitioners disagree with this decision they have no choice but comply with medicines law in the UK, irrespective of whether other national medicines regulators in the EU have not taken this stance.

Food supplements, are they foods?

Yes by EU Definition of “food“ or “ Food Stuff” means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. Therefor food law applies food supplements to. Food Supplements (dietary/ nutritional supplements) must comply with all relevant aspects of food legislation in terms of composition, manufacture and control at both an EU and National Level, all EU laws have their own UK equivalent, which is basically the same law transcribed into UK law.

 Sports Drinks, are they foods?

Yes, all drinks have to comply with food law, just like food supplements. However they are also considered Foods For particular Nutritional uses (PARNUTS or PNUs) sometimes referred to as dietetic products under Directive 2009/83/EC. This directive establishes general rules and that one day they will get around to writing regulations for foods for the expenditure of intense muscular effort (food for sports people). This is still at draft stage; however there is a Scientific Committee on Food (SCF) report on foods for expenditure for intense muscular effortand a EFSA report on carbohydrate-electrolyte solutions. Further guidance on this can be given on request.