Cosmetics manufacturers moving into supplement and food related beauty products need to watch out for growing nutraceuticals legislation
Cosmetics manufacturers thinking about adding nutricosmetics, or nutraceuticals, to their preparations need to be aware that the EU keeps a special watch on these additives. And while the current regulations are not worrying, the net is being slowly tightened.
The term nutraceuticals is taken by Brussels to mean “concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet”. But the laws covering the sale of such items are unclear. For instance an EU food regulation dating back to 2002 (EC 178/2002) lays down general principles for food supplements and another in 2006 (1924/2006) sets out the conditions applying to nutrition and health claims. But the latter lays down specific compositional rules only for vitamins and minerals.
Few cosmetics firms use these nutraceuticals on any scale at present. Colipa was unable to identify any significant usage of nutraceuticals by its members. Similarly in the US the Personal Care Products Council (PCPC) could not identify nutraceuticals being used as ingredients by cosmetics firms. The US Food and Drug Administration (FDA) declared that the term was not used in America, but that additives of this kind “would be regulated as dietary supplements in the US and pre-market review or approval is not required”.
But nutraceuticals are real and being used to improve beauty. A European Commission spokesperson said that if preparations containing chocolate, coffee or fruit are “consumed orally” then they are subject to food labelling regulations. If applied to the skin they are considered cosmetics, even if they are designed to allow the body to absorb nutrition. Any cosmetics manufacturer with an eye on the ball will have sussed out the rules applying to food in the event that they launch a product that is ingested. But they need to be careful – nutraceuticals is a growing sector and special rules are being written for it.
The only legislation applying specifically to nutraceuticals is the so-called food supplements directive approved in June 2002 and numbered 2002/46/EC “on the approximation of the laws of member states relating to food supplements”. Prior to this all legislation covering nutraceuticals was in the hands of the individual national EU governments and certain aspects remain so today, though on a diminishing basis.
The purpose of EU nutraceutical legislation is to ensure that products are “safe and appropriately labelled so that consumers can make informed choices”. Directive 2002/46/EC provides an annex comprising a list of permitted vitamin or mineral preparations “that may be added for specific nutritional purposes in food supplements”. An amending directive in 2006 extended this list. Since August 2005 the marketing of products containing vitamins and minerals not listed in annex II has been prohibited, though vitamins and minerals may be added if okayed by the European Food Safety Authority (EFSA).
As to permitted levels, Article 5 of the directive indicates that “maximum amounts of vitamins and minerals for food supplements have to be established by the Commission as an implementing measure through the comitology”. This means that the levels are decided at special committee meetings between Commission officials and representatives of the member states. The Commission services “have initiated discussions with member states on this subject on the basis of the above criteria,” a Brussels spokesman told SPC. These discussions are aimed at deciding the actual maximum levels of permitted minerals and vitamins and whether other substances should be put on the list.
At the same time there are vitamins and minerals used in food supplements marketed in member states which have not undergone a scientific safety evaluation. To allow time for such evaluation, member states have been allowed to provide derogations (temporary exemptions) until 31 December 2009 for vitamins and minerals and their forms not included in the directive, after which they will be added to the list of substances in the annexes.
A second EU directive approved in 2006, the health and nutrition claims regulation, sets out the permitted and not permitted claims about health that may be made by manufacturers. The regulation will ban information about foods and their health benefits used in marketing “which is not clear, accurate and meaningful and cannot be substantiated”. Weight control claims will be outlawed, as will endorsements by health professionals “as they might suggest that not eating the specified food might lead to health problems”.
Clearly the 2006 directive will impact on cosmetic manufacturers using nutraceuticals. As for Directive 2002/46/EC, this will depend on how high the permitted levels for minerals and vitamins is set and what new substances are brought under the controls. Inevitably there will be a sharp diminution of the number of authorised nutraceuticals as these aspects of the directives are brought into play.