EU Enzyme LegislationI came across this in my research............last sentance...places a huge responsibility on the producers.
EU ENZYME LEGISLATION
May 2006
Legislation and responsibility for traceability and food safety
An enzyme producer replies
Patrice PELLERIN(1), Céline BAJARD-SPARROW(1), Céline FAUVEAU(1), François STROZYK(2)
(1) DSM Food Specialties, Parc Scientifique Agropolis II Bât 5, Bd de la Lironde, 34 397 Montpellier Cedex 5, France
(2) DSM Food Specialties, BP 50 239, 59 472 Seclin Cedex, France
Editorial Comment: The following paper discusses the legislation with regard to wine producers in the European Union, but highlights the developments that we may expect in South Africa in the near future. These developments should be particularly relevant to those producers currently exporting to, or intending to export to the E.U.
Those operating in the wine industry must now ensure the traceability and quality of their products, with greater guarantees being required internally and from their suppliers; regulatory and marketing requirements have been tightened over the last few months. The role of additives and processing aids suppliers, is to assist wine producers by providing them with all the necessary information to meet legislation and distribution network requirements. DSM Food Specialities has a policy committed to reliability and transparency, offering high quality products with appropriate certification.
1. The new European regulation and its effects on wine producers.
From 1st January 2005 the European Regulation EC 178/2002 on food safety has applied in France and the E.U. This new legislation makes all those operating in wine-growing and wine-making aware of their duties as a responsibility for results now replaces the previous responsibility for resources. In other words, under European regulations, producers are now fully liable for the safety of their end product. Those operating in the food industry have to prove they have made every effort in this respect, with traceability now being required at all stages in production.
Those operating at any stage "from the vine to the glass", must work together to ensure complete transparency in the field of food safety. Producers of œnological products have a joint responsibility with the wine producers for ensuring the safety of wine.
Thus, transparency is ensured, enshrined as a basic principle in this new legislation. An operator in the food chain must be able to rapidly notify the authorities of any problem occurring so that faulty products can be withdrawn from the market and consumers advised as quickly as possible. There is, of course, a joint responsibility throughout the chain of production to ensure food safety, particularly in respect of allergies.
Following a period of highly publicized food crises (BSE, food allergies etc.) the distribution chain is demanding a number of guarantees from its suppliers regarding their products, with the implementation of such control systems as BRC and IFS. Purchasing centers exercise direct pressure on the nature and traceability of source products and products used during the course of wine making. Their requirements are often more demanding than the current Regulation, with highly restrictive responsibilities in respect of resources.
Thus, producers have to respond to the requirements of both regulatory and the market controls. In turn, they have to make similar demands on their own suppliers (grape producers, manufacturers of œnological products and dry materials etc) and sub-contractors. In order to help with choosing and purchasing œnological enzymes, DSM Food Specialties has drawn up a comprehensive questionnaire (see questionnaire box below) for wine producers to give to their supplier(s). Although most of the points covered in this article are concerned with œnological enzymes, a similar approach can be applied to all the ingredients and associated technology used in vinification.
Questionnaire for submission to your enzyme supplier.
Respecting the legislation
Do your enzymes meet current legislative requirements (International Wine Organization, European Union, Joint Expert Food Committee, Food Chemical Codex)?
Are your enzymes produced from the microorganism strains authorized by European legislation?
Did you make a prior request for marketing authorization for your enzymes to the DGCCRF?
Œnological quality of the enzymes
Are your enzymes specifically formulated for œnological purposes?
Do your enzymes give rise to cynnamyl esterase or anthocyanase activity?
Have your products been subjected to a phsyio-chemical purification process?
What quality guarantees do you provide regarding enzyme production?
Safety of food products
Have toxicity studies been carried out on your products?
Can you state whether or not there are allergenic substances in the production process or formulation of your enzymes, or in any other product used in the production chain?
What safety guarantees do you provide for using these enzymes?
GMO Transparency
Are the microorganisms used to produce your enzymes improved by genetic engineering?
Can you guarantee that these microorganisms do not contain any foreign DNA?
2. What are the enzyme supplier's duties under the regulations?
The recommendations of the OIV (Office International du Vin) and European and French Regulations, are rather like the Russian doll, as they wrap around one another with degrees of precision and ever increasing legal restrictions. While the new International Œnological Codex and the IWO Code of Œnological Practice both recognize the use of enzymes where their effectiveness has been demonstrated (resolution 14/2003), and for a whole series of applications (resolutions 11 to 18/2004), European and French legislation is rather more restrictive and is based on the principle of an approved list. So the EC Regulation 1493/1999 only authorizes pectin from Aspergillus niger, b-glucanase produced by Trichoderma harzianum, urease from Lactobacillus fermentum and lysozyme. In addition to the approved list principle, French regulations imposed further restrictions with the Enzyme Decree of 5th September 1989, which aims to guarantee food quality and safety. It is worth mentioning that few countries have such meticulous regulatory provisions. The Decree requires that marketing an enzyme on the French market be subject to a prior marketing approval or declaration from the DGCCRF.
It is therefore up to the users of œnological enzymes to question their suppliers in order to establish that their products satisfied the requirements of the procedure before being marketed.
The general policy of DSM is to scrupulously respect all current legislation in force in the various geographic areas where the company operates. All the œnological enzymes marketed in France and produced at our plant at Seclin (in the urban area of Lille, France) comply with the regulations. Respecting the legislation specifically includes the choice of production microorganisms (Aspergillus niger and Trichoderma harzianum), primary and secondary enzyme activity, and the exclusion of non-authorized activity such as that of protease and cellulase.
Finally, our micro-granulated enzyme preparations can be kept under recommended storage conditions without the need for added preservatives.
3. Using high quality enzymes
Other important questions arising when choosing the enzymes used in vinification are:
- What level of quality can a wine producer expect of œnological products?
- What are the quality standards operated by the supplier?
International standards offer excellent guarantees in this respect. The DSM enzyme production plant, which has been certified ISO 9002 since 1993 and ISO 9001-2000 since 2003, applies HACCP2 principles. The production site is often audited by major world food companies. Thus, our customers have the benefit of products that have been obtained in accordance with the highest standards of production and quality control.
Our œnological enzymes are produced from the fermentation of pure cultures of selected microorganisms. Moreover, all the formulae have been designed for specific œnological applications, validated by experimental vinification and then by wineries during trials conducted by the DSM technical service. Full-scale trials enable the effectiveness of products to be checked and to ensure there are no unwanted side effects.
In fact, commercially produced enzyme may have two types of undesirable effects. These are cinnamyl esterase and anthocyanase. Although the secondary effects are tolerated under the legislation, both these enzymes activities spoil the quality of the wine. Cinnamyl esterase activity contributes to the formation of volatile phenols, which are responsible for off-smells (poster paint and nail polish in white wines and horse sweat and stable smells in red wines). Anthocyanase can cause a reduction in color in red wines. The wine-maker must be sure that enzymes used do not have a negative effect on color and that concentrations of vinyl and ethyl phenols remain below the olfactory perception threshold.
DSM enzymes come from strains that have been selected to ensure they naturally produce lower levels of undesirable activities than those of enzymes know as "purified" or low in cinnamyl-esterase. Purification is itself an onerous process and reduces the range of secondary activities that are of real value in vinification.
In addition, œnological enzymes should not contain sorbate salts, although this authorized preserving agent is found in some liquid enzyme preparations. In fact, sorbic acid can be metabolized by several species of lactic bacterium, including Oenococcus oeni. This deterioration leads to the formation of 2-Ethoxyhexa-3.5-Diene, which gives a particular, geranium leaf off-smell. Since the perception threshold is very low the risk of adversely affecting the aromatic quality of the wine should not be overlooked.
4. How can a non-toxic product with no allergenic substance be guaranteed?
To ensure the consumer's health and meet the requirements for transparency, a wine producer has the right to ask for guarantees from œnological product suppliers and must in fact do so. The attached questions cover some of the main worries in this area.
Firstly, while it seems obvious that non-toxic ingredients should be used for making a food product, non-toxicity has to be proven. Before marketing a new product, DSM carries out a systematic in-depth toxicology examination in the lab, following the principles of the Scientific Committee for Human Food and / or that of the French Agency for Food Safety.
An increasing number of people are suffering from food allergies or an inability to tolerate a substance and look forward to drinking wine that is free of allergens. This requirement is reflected in the terms of reference of major distribution chains (IFS etc), requiring meticulous monitoring of associated technology and additives that might give rise to allergies (see box with the allergenic ingredients listed by European Directive 2003/89). Here again, wine producers need suppliers who have an existing policy on traceability and quality assurance. DSM simplifies their task with a three-fold check that products are allergen free: firstly by the final composition of the enzymes, secondly by better culture of production microorganisms, and thirdly by limiting cross-contamination. Such an approach enables extremely precise certificates to be supplied on "allergen hazard information" Moreover, an approach is in hand to restrict the use of identified allergens by Directive 2003/89.
Although œnological enzymes are not directly implicated, it would seem opportune to review labeling on allergens (even where only trace elements are present) in wines. While the presence of sulfites must be declared with effect from November 25th 2005, other substance likely to cause allergies (lysozyme, albumin, vegetal and animal fining proteins…) are given a moratorium until November 2007 (EC Directive 2005/26). This moratorium was decided upon so that the wine trade would have time to demonstrate that treating wine with certain of the listed products is allergen hazard-free (lysozyme, albumin, isinglass, vegetable protein etc.) The results of these studies will determine future wine labeling requirements.
The 12 groups of allergenic ingredients listed by European Directive 2003/89 (Appendix III B) for labeling food products.
Cereals containing gluten and cereal-based products.
Shell fish and shell fish-based products.
Eggs and egg-based products.
Fish and fish-based products.
Peanuts and peanut-based products.
Soya and soya-based products.
Milk and milk-based products.
Nuts
Celery and celery-based products.
Mustard and mustard-based products.
Sesame seeds and sesame seed-based products.
Sulphurous anhydride and sulfites at concentrations of over 10 mg per kg or 10 mg per liter expressed in SO2
5. GMO Transparency
Speaking of GMOs in respect of enzymes causes confusion. Genetic modification techniques apply only to productive microorganisms strains and not to enzymes themselves. In fact, enzymes are proteins and not living organisms! Yet they can be produced by microorganisms that have been obtained by genetic modification. Thus, we can speak of an enzyme as being produced by a genetically modified microorganism.
Details of genetic engineering techniques and their advantages in œnological use are not discussed in this article. We hope however to provide œnologists with some advice on the status of the enzymes they use. The questions in the last paragraph of the attached questionnaire must be raised so that any ambiguity is avoided, for instance "this enzyme is not a GMO" or "according to the legislation of such and such a country…" etc According to the technique used and the country concerned, there are several interpretations of the term "genetically modified organism" even within the European Union.
Only specific questions on the conditions for obtaining the productive microorganism strain for the enzyme will provide reliable information on whether genetic engineering was used.
Biotechnology companies are not opposed to the use of genetic engineering. However, such techniques should only be used where full transparency is exercised in respect of clients and when their use is generally agreed upon in the market and among consumers. This may be the case when the use of genetic engineering enables health risks to be avoided or recurring technical problems to be resolved.
CONCLUSION
It must be remembered that producers are legally liable for both the quality and traceability of their wines. They must apply strict internal control measures and request full guarantees from their suppliers in order to make and market their wine in all confidence, certificates to hand!