Novel food regulation

Opinion of the Scientific Panel on Genetically Modified Organisms on a request from the Commission related to the safety of foods and food ingredients derived from insect-protected genetically modified maize MON 863 and MON 863 x MON 810, for which a request for placing on the market was submitted under Article 4 of the Novel Food Regulation (EC) No 258/97 b y Monsanto. European Food Safety Journal 2004 (50) 1—25. 

The inconsistency remains, as the new regulation does not apply to crops regulated under the Novel Food Regulation or highly processed products such as flavorings... 

While the text of the final resolution recast of the European Union s Cosmetics Directive may have been the first national or supranational instrument to be passed by a Parliament with nano-specific provisions within its text, it will certainly not be the last. The Eurojjean Parliament and Council is still to vote on the inclusion of nano-specific provisions in the recast of its Novel Food Regulation and nano-specific amendments to the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACFI) Regulation (Regulation (EC) No 1907/2006) appear inevitable. While such measures are jurisdiction specific, their impact—it passed—will be felt more widely non-European parties wishing to place products onto the European Community market will be required to comply with such instruments. As such, regulatory action within any one jurisdiction will have an impact beyond their territorial boundaries. 

Huggett, A.C., and C. Conzelmann. 1997. EU regulation on novel foods Consequences for the food industry. Trends Food Sci. Technol. 8 133-139. 

Regulation (EC) No. 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (http //europa.eu.int/eur-lex/lex/LexUriServ/ l,exUriServ.do uri=CPJE.y 31997R025R EN HTMl,i... 

Genetic engineering has also to be mentioned. At first all novel food products have been regulated by Directive 90/220/EEC. Later the Regulation (EC) No. 1829/2001 on genetically modified food and feed was issued covering both food additives and flavourings [88[. 

EC (European Commission) (1997). Regulation 1997/258/EC of Jan. 27, 1997, concerning novel foods and novel food ingredients. 

EC Commission decision of 31 March 2004 authorizing the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese-type products with added phytosterols/phytostanols as novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council [notified under document number C(2004) 1243]. Official Journal 2004, L 105,14/04/2004, 0040-0042. 

Canada Food and Drugs Regulations (Canada, 2001) Food additive, novel food... 

European Union European Communities (Infant Formulae and Follow-on Formulae) Regulations, 1998 (FSAI, 1999) Council Directive 89/107/EEC (EEC, 1989) European Parliament and Council Directive 94/34/EC (EEC, 1994) Regulation EC No. 258/97 (EC, 1997) Council Directive 90/220/EEC (EEC, 1990) Established by generally accepted scientific data Food additive Food additive Novel foods, novel food ingredients Genetically modified organisms... 

There are no explicit requirements for preclinical testing of infant formulas specified under Canada s Food and Drug Regulations in Division 16 (Food Additives), Division 25 (Infant Formulas), or Division 28 (Novel Foods) (Canada, 2001). Divisions 16 and 28 require that a notification be submitted to Health Canada that includes information used to establish the safety of a food additive or a novel food. Health Canada refers manufacturers to internationally accepted guidelines for preclinical testing or asks to be consulted because decisions are made on a case-by-case basis. 

Similarly, in Canada there are no explicit guidelines or requirements for in-market surveillance of infant formulas specified under Canada s Food and Drug Regulations in Divisions 16 (Food Additives), 25 (Infant Formula), or 28 (Novel Foods). 

European Parliament legislative resolution of 24 March 2009 on the proposal for a regulation on novel foods, A6-0512/2008. 

Currently, the main problem consists of rapeseed proteins classified as novel food according to the EU regulations, which does not allow its use as food or food additive before passing time and cost-consuming admission procedures. 

Similarly to the biosafety programme, the main outcome of the foods and feeds programme is the set of Consensus Documents on compositional considerations of new varieties of specific crops. The Task Force documents compile a common base of scientific information on the major components of crop plants, such as key nutrients, toxicants, anti-nutrients and allergens. These documents constitute practical tools for regulators and risk/safety assessors dealing with these new varieties, with respect to foods and feeds. To date, 20 Consensus Documents have been published on major crops and on general considerations for facilitating harmonisation. They constitute the Series on the Safety of Novel Foods and Feeds which is also available on the OECD s website at no cost (www.oecd.org/biotrack). 

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