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ENAC designated for good laboratory practice certification of food additives, flavourings and enzymes, novel food and co-adjuvant technology

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18th May 2018 Industries

The Spanish Ministry of Presidency and Territorial Administrations have designated ENAC as the inspection and certification body for Good Laboratory Practices (GLP) in non-clinical health and environmental safety trials of additives, food flavouring and enzymes, novel food and co-adjuvant technology.

These Good Laboratory Practice studies are essential for enabling the competent authorities to register and enter new products, which are to be used in the food chain, on the market.

The GLP principles were adopted by the OECD and subsequently by the European Union by means of directives, to guarantee the quality and validity of data obtained from the studies carried out when registering new substances. So far, Spain has not appointed the GLP inspection body for studies for additives, food flavourings and enzymes, novel food and artificial co-adjuvants.

With this designation, the competent national authorities regulating these products comply with European legislation and have confidence in ENAC to inspect and certify the bodies and laboratories carrying out the studies to obtain data and information related to the danger facing people, animals, the Environment and these products.

It is necessary to stress how important these products have been over the years, as more and more new varieties of artificial ingredient are made, such as additives, food flavourings and enzymes and artificial co-adjuvants to satisfy food needs. They are necessary to maintain or improve safety, freshness, flavour, texture or appearance of processed foods and keep them in good condition during transportation from factories or industrial kitchens to consumers. Today it would not be possible to market many foods available on the market without using these ingredients.

The case of the so-called "novel food" is different; these are defined as food that were not widely consumed by human beings in the EU before 15 May 1997, either because they hadn't entered our borders, or because they were created by innovative techniques. Examples of novel food include new sources of vitamin K (menaquinone) or extracts from existing foods (Antarctic Krill oil rich in phospholipids of Euphausia Superba), agricultural products in third countries (chia seeds, noni fruit juice) or food derived from new production processes (food treated with UV radiation).

In Spain the national food industry additive trade reached a value of €500 million in 2017, there are currently around 150 companies operating in Spain, so this ENAC designation for BPL certification makes it easier for Spanish manufacturers and laboratories carrying out tests for these product types to get approval and get access to essential certification to sell new products. In addition, companies will benefit from the data generated by ENAC's GLP-certified bodies as they will be accepted by any signatory country of the "Mutual Acceptance of Data" the OECD agreement, eliminating trade barriers.

For ENAC, it is a new recognition of the work carried out in this field since it was designated a Good Laboratory Practices inspection body for plant protection products in 1995, for Industrial chemical substances in 2008 (including biocidal products), and for food additives in 2014. With this designation, Spanish legislation therefore covers all product types requiring GLP to be authorised by the European Commission.

This designation gives ENAC the possibility to respond to the sector's growing needs to have certified GLP test bodies in Spain for these types of products.


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