NEW REGULATION UNIFIES TECNOLOGICAL ADJUVANTS
Recently it has been published Royal Decree 773/2023, regulating the technological adjuvants used in food production and manufacturing processes in Spain. This regulation unifies the technological adjuvants authorised in food production processes and guarantees the safety of their use and controls.
WHAT ARE TECHNOLOGICAL ADJUVANTS?
Technological adjuvants are ingredients that are intentionally used in food processing to fulfil a technological purpose. However, unlike food additives, enzymes and flavourings, they do not have an impact on or are not present in the final product, although residues of the substance itself or its derivatives may be found in the finished product.
For example, in the production of food supplements based on omega-3 fatty acid, organic solvents are used to extract omega-3 from fish oil, but once their function is fulfilled, they evaporate and have no effect on the final product.
HOW ARE TECHNOLOGICAL ADJUVANTS REGULATED?
There is no harmonised regulation for technological adjuvants in the European Union. The only reference to this ingredient is found in Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, which defines technological adjuvants, but expressly excludes them from its scope of application. Therefore, the applicable legislation is the one that exists in each case in the Member States of the European Union.
In the case of Spain, to date the regulation of technoligal adjuvants has been divided into twenty sectoral rules. This new Royal Decree brings together the authorised technological adjuvants in a single standard and establishes specifications for their labelling.
In contrast to this unification, there are some exceptions: the list of technological adjuvants authorised for the production of edible vegetable oils (regulated by Royal Decree 640/2015) and cases in which the application of other legislation is applicable do not fall within the scope of this Royal Decree. Likewise, in relation to the adjuvants that have been used in foods of animal origin, this royal decree only includes those used in the preparation or obtaining of edible fats, margarines, minarins, fatty preparations, cephalopods, bones, tripe, natural casings and haemoderivatives.
HOW DOES THIS RULE AFFECT FOOD SUPPLEMENTS?
By unifying the authorised adjuvants in a single text, this regulation facilitates their consideration and application by economic operators and control authorities, simplifying their work and thus providing them with greater healthy safety and legal certainty.
In order to simplify consultation of the conditions of use of the various adjuvants, Annex I is divided into two parts. Part A lists the foodstuffs included in the scope of application of the Royal Decree together with a reference to the legislation defining them, while Part B lists all the authorised technological adjuvants, the foodstuffs in which they may be used, the category to which they belong, the conditions of use and/or the function they serve and the maximum residual quantity that may remain in the final product.
This regulation represents an important update to the reality of the use of technological adjuvants: it eliminates those that have become obsolete and incorporates new authorised substances that did not have a regulatory basis but did have a safety assessment.
DOES THIS RULE RESTRICT THE AUTHORISED TECHNOLOGICAL ADJUVANTS?
No, this Royal Decree unifies the technological adjuvants authorised in Spain, but in accordance with the principle of mutual recognition, technological adjuvants that are legally marketed in other Member States of the European Union may be used, with the same restrictions and limitations that exist there and for the same purpose.
In addition, substances not listed in Part B of Annex I to the Royal Decree may be used as technological adjuvants, as long as they are permitted as food additives and it can be demonstrated that they meet the requirements set out in the definition of technological adjuvants.
Not only does it not restrict the authorised technological adjuvants, but it also lays the foundations for amending the list of permitted technological adjuvants, thus ensuring greater protection of the health of consumers. Specifically, the Royal Decree states that the authorisation of new technological adjuvants will require a report from the Scientific Committee of the autonomous body of the Agency for Food Safety and Nutrition (AESAN OA) certifying the absence of risk to the consumer and a favourable opinion from the Ministry of Agriculture, Fisheries and Food.