E.U. - FEFANA opens paths for the authorization procedure for new and existing “Dietetic complementary feed” products
Concentrated feed additives products are now ruled under the Regulation on the placing on the market and use of feed
On 1 September 2009, the new Regulation (EC) 767/2009 on the use and placing on the market of feed was published in the Official Journal of the European Union. After a long time without a legal home, products containing high feed additive concentrations (also known as ‘Nutritional Supplements’) are now ruled under this new Regulation and will be classified as “Dietetic Complementary Feed”. A transition period of one year is foreseen to take care of a Community authorisation for those products already on the market. FEFANA is coordinating these procedures on behalf of its members.
A wide range of products containing high feed additive concentrations (such as boluses, drenches, and a number of water applicable products, pastes and others) lacked an unequivocal regulatory classification in the EU. As supported by FEFANA since the revision of the feed additives legislation, the Community legislator has now clarified the situation by giving this type of feed a legal home in the Regulation on the placing on the market and use of feed. FEFANA strongly appreciates this move forward which will create transparency and harmonization on the EU market, to the benefit of the operators placing these products on the market and those using them.
The new regulation, which will be applicable from 1 September 2010, is classifies concentrated products, depending on their level of feed additives, as either complementary feed or feed for particular nutritional purpose (“dietetic complementary feed”). At a low concentration of additives, products will be seen either as complementary feed or as dietetic feed as in the past. However when the concentration of certain additives exceeds 100 times the maximum permitted limit in complete feed, the product will only be considered as a dietetic feed, as soon as it conforms to the requirements of the list of particular nutritional purpose, maintained through an authorization system, covered under this new Regulation.
In the context of such authorisation, operators must take into account that:
- products should fit to a particular nutritional purpose as laid down and listed in Directive 2008/38
- products, already placed on the market, need to be notified in order to remain on the market in the future
Operators must comply with these requirements to ensure that their products remain on the market. The application process, in particular as regards existing products and the requirements for a valid application, is not detailed in the new Regulation. Furthermore, guidelines for application need to be worked out together with the European Commission which is competent to receive the applications.
FEFANA, the EU Feed Additives and Premixtures association, is taking up this task with its members and has started coordinating the necessary actions. Discussion has been launched with the Commission upon the abovementioned issues in order to take necessary steps and to secure access to the market for the existing products. In the absence of a precise way forward from this new regulatory text, the timeframe foreseen by the Regulation is narrow.
The current official list of particular nutritional purposes is incomplete to cover all existing speciality products and thus new particular nutritional purposes need to be opened; additionally, the existing ones may have to be expanded, and each specific product needs to be matched with a particular nutritional purpose. Where such purpose does not yet exist, its opening will have to be supported by the notification of the products, it aims at covering.
It is important to note that the transition period in the Feed Marketing Regulation foresees a deadline for the submission of applications (and therefore the notification) at the time of its applicability, i.e. by September 2010.
FEFANA is keen to welcome companies placing such specialities and additives concentrates on the market, which are subject to these new requirements, to prepare the submission path and coordinate it with its members. Interested EU operators are invited to contact the FEFANA Secretariat: Tel.: +32 (0)2 639.66.60; Fax: +32 (0)2 640.41.11; E-mail: firstname.lastname@example.org
FEFANA is the EU Feed Additives and Premixtures Association. It was established on 13 October 2004 and is the new juridical form of the feed additives producers association that was founded in 1963. With more than 100 members from 28 countries, the Association is the interface between the feed additives industry and the European Union authorities, including Member State authorities, in order to promote, safeguard and defend common and general interests of the industry (in several topics like guidelines, register, labelling and definitions, analysis, feed hygiene and food chain safety or non-feed use of additives). FEFANA’s chairperson is Dr. Hadden Graham of AB Vista.