CAPÍTULO 6. ANÁLISIS DE RESULTADOS
6.3. LA POLITIZACIÓN DE LAS SUBJETIVIDADES EN LAS REDES DE MOVILIZACIÓN VIRTUAL Y
6.3.1. Expresiones subjetivas: medios, lenguajes e interpelación en las narrativas
(the ‘Food Additives Framework Directive’) and the subordinate legislation. Nanofood additives are assessed either as novel additives or, where a macro- equivalent is already approved, through potential amendments of the appro- priate specifications, including purity criteria, under the Directive 2008/84/EC.
From 2010 on the Food Additives Framework Directive will be replaced by a common authorisation system, with the European Community having adopted a set of Regulations, which will provide for a common basis of controls on food additives (Regulation (EC) No. 1333/2008), food enzymes (Regulation (EC) No. 1332/2008), and food flavourings (Regulation (EC) No. 1334/2008). Moreover, the adoption of the common authorisation procedure will bring together all of the existing food additive regulations, and introduce comitology for the approval of the three categories of substances. Moreover, in line with the decision to separate risk assessment and risk management, under the new system, all applications for the approval of each category of substance will be directed to EFSA, who will carry out the safety evaluations and risk assess- ment. Pursuant to the new Regulations, a positive list (‘Community list’) will be established for each substance category. As noted by the European Commis- sion, ‘the inclusion of a substance on one of these lists means that its use is authorised in general for all operators in the Community’.33
Note that a ‘food additive’ is defined (in Article 3(2) Regulation (EC) No. 1333/2008) so as to mean ‘any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods; . . . ’
In addition to the safety of the substance, the other general criteria (tech- nological need, consumer aspects) will have to be examined before a food additive may be included in the positive list. Under the new Regulation, this would be done by the Standing Committee on the Food Chain and Animal Health (SCFCAH). For an authorised food additive to be included on the proposed positive list, a specification must be laid down that contains the cri- teria on purity and defines the origin of the food additive or enzyme, and the verification of such criteria (for food additives, see Preamble 8 and Article 14 Regulation (EC) No. 1333/2008; for food enzymes, see Preamble 8 and Article 7 Regulation (EC) No. 1332/2008).
The most relevant aspect in relation to the use of nanoscale food additives in the new Regulation is arguably the re-evaluation of safety assessment, which will ensure that food additives, once permitted, are kept under continuous obser- vation and re-evaluation. Therefore, under the new Regulation, producers or users of food additives which are ‘significantly different from those included in the risk assessment of the Authority or different from those covered by the specifications laid down’ will be obliged to inform the Commission of any new information that may affect the safety assessment of a food additive. As stated in the proposal, a ‘significant difference’ could mean inter alia a change in the manufacturing process or in specifications, changing conditions of use, any new scientific information, or ‘a change in particle size’ (see Preamble 12 of the Regulation (EC) No. 1332/2008 in relation to food enzymes). Based on the new definition, the use of nanotechnology will constitute a ‘significant difference’ for the purpose of re-evaluation by the EFSA, and is an important inclusion in the new Regulation. Moreover, under the new Regulation, the EFSA will also be invested with the power to re-evaluate a food additive on the basis of ‘new sci- entific information’ (Preamble 14 of Regulation (EC) No 1333/2008). While it is unclear at this time whether or not ‘new scientific information’ would be inter- preted so as to include development in nanotechnologies, it is argued that the express inclusion of ‘change in particle size’ in the new Regulation may be relevant for triggering re-evaluation by the EFSA.27
A potential limitation of the proposed regulatory regime in relation to nanoparticles appears to be the current lack of information to describe ade- quately the food additive; that is, to ensure that all relevant aspects that cor- respond to the additive have been assessed for safety. While it is provided that the previous food additive specifications would be maintained until the corre- sponding additives are entered into the Annexes of any new Regulation, there are as yet no criteria within the specifications that cover the use of nanoparticles 157 Small Ingredients in a Big Picture: Regulatory Perspectives on Nanotechnologies
per se. For example, in the case of a coating intended to provide moisture or oxygen barrier to confectionery products (Mars Inc.’s US patent US5741505), the purity specification for silicon dioxide (E551) describes only the process by which SiO2may be produced for food additive use (in other words, no defi-
nitions for source materials are prescribed). However, the source compounds for SiO2used in the production of the nanoscale SiO2coatings includes orga-
nosilicates, silanes, chlorosilanes and tetraethylorthosilane. In addition, the current EU purity specification for SiO2 (E171) does not prescribe criteria
related to particle size, which clearly is a principal issue in terms of the use of nanotechnologies. This additive was last evaluated in 1977.
Food processing aids, specifically, are not included within the scope of the new Regulation. This may have implications on the use of certain nano- technologies. For example, carrier systems used to protect additives during processing only appear under the auspices of novel foods. It is clear that food additives must at all times comply with the approved specifications. The defi- nitions laid down in Article 3(2) of the new Regulation list certain substances that are not to be considered as food additives. Among these are substances being used as, for example, nanomicelle-based carriers, which have the potential to lead to a blurring of the distinction. This occurs, for example, in certain types of dextrin and modified starches, gelatine and products containing pectin.
See Article 2 of Regulation (EC) No. 1333/2008: pursuant to Article 3(b), ‘a ‘processing aid’ shall mean any substance which: (i) is not consumed as a food by itself; (ii) is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and (iii) may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product; . . . ’