Food enzymes, what rules in the EU? The lawyer Dario Dongo responds

Dear Dongo Lawyer,

it is possible to request authorization in the European Union of food enzymes under the same conditions presented by other applicants, who have already received EFSA approval (European Food Safety Authority)?

Many thanks, James


The lawyer Dario Dongo, Ph.D. in international food law, answers

Dear James,

the regulation of food enzymes in the European Union is still incomplete and is therefore also a cause of judicial uncertainty. A brief insight to follow.

1) Food Improvement Agents Package. Premise

Food Improvement Agents Package (Reg. EC No 1331-1334/08) introduced a uniform regulation to be applied in the Old Continent to food additives, enzymes and flavourings. This regulation includes a common authorization procedure which must precede the introduction of 'Food Improvement Agents' into the single market and includes a safety assessment by EFSA.

Applications for authorization, to be presented through the E-Submission Food Chain (ESFC) Platform, must be accompanied by specific dossiers, the compilation of which must consider:

– the procedure established in Reg. (EC) No 1331/08 and Reg. (EU) No 234/2011, as amended by Reg. (EU) No 562/2012, containing measures for its implementation. With particular regard to the specific data necessary for the scientific risk assessment;

– the provisions of Transparency Regulation (EU) No 2019/1381, which amends the General Food Law (Reg. EC No 178/2002) in the part relating to the transparency and confidentiality requirements of the information and scientific studies presented by the applicants.

2) Food Enzymes Regulation

Food Enzymes Regulation (EC) No 1332/08, within the FIAP, provides that all authorized food enzymes be included in a specific European list (Article 4). (1) Furthermore, this list has not yet been published in the more than 15 years since the entry into force of the ERF.

On hold of the fateful list above, the European Commission has instead published a 'register' where all the applications submitted by interested parties are recorded within the period of 42 months from the date of application of Reg. (EU) No 234/2011. (2)

3) Food enzymes, new authorizations

In theory an enzyme already authorized in the European Union should not need to receive new authorizations. However, the failure to publish the list of enzymes authorized in the EU and the recurrence of evaluations of similar dossiers has led the companies involved to submit authorization applications.and following the best practices', to prevent the risk of seeing one's enzymes possibly excluded from the possibility of being placed on the market.

The presentation of a new application for the evaluation of a food enzyme included in the 'register' and already evaluated by the Authority is possible, although the Commission has the right to terminate the uniform procedure - duly informing the applicant, with a reasoned act - when considering the request of 'unjustified' authorization. In the legal uncertainty that arises from this scenario, it appears useful to recall the rules and precedents observed so far.

3.1) Submission of applications

The submission of authorization applications must follow the provisions of Reg. (EU) No 234/2011, which recalls the need to consider the Commission's 'practical guide for the submission of applications' and the latest guidance documents adopted or approved by EFSA at the time of submitting the application.

EFSA in turn clarified, in 'Scientific Guidance for the submission of dossiers on Food Enzymes' (3) that:

– the submission of the data required for the risk assessment may not be necessary, if the application concerns a modification of the conditions of use of an already authorized enzyme or a modification of its specifications (the relevance of which must however be assessed on a case-by-case basis), (4)

– 'significantly different' production methods (of the enzyme) or raw materials must instead be subjected to evaluation by the Authority.

– applicants are always and in any case obliged to notify new scientific or technical information that may affect the safety assessment of the food enzyme.

3.2) Simplified risk assessment

The simplified procedure for risk assessment can be invoked by the applicant if one or both of the following conditions are met:

– introduction of a new production process, to be described in its entirety with a note on the proposed changes. Risk assessment and additional toxicological tests, where appropriate, are required if the composition of the non-enzymatic components changes (i.e. Total Organic Solids),

– extension of use of the enzyme in other food production processes, to be reported with a complete description for each use. To be integrated if necessary with the calculation of food exposure resulting from new uses. (6)

3.3) Previous opinions. Example 1

An example of updating the safety assessment of a food enzyme concerns the extension of use of α-amylase (obtained from the non-genetically modified AE-AMT strain of Cellulosimicrobium funkei) in production processes different from those proposed by the initial applicant within the 42 months for inclusion in the register.

The only additional information provided for the safety assessment concerned the food processes, the raw materials where the enzymes were used and the maximum recommended use levels (mg TOS/kg of raw material), supplemented by data on the resulting increased dietary exposure.

The question falls within the scope of application of the Transparency Regulation, EFSA therefore had to include all the information reported in the relevant technical dossier on Open EFSA. The additional information compared to the first dossier reported by the new applicant, in addition to the administrative data and the 'public summary', is:

1) detailed summary;

2) identity, characterization and specification of the enzyme(s): i) characterization of the enzyme;

3) risk assessment: i) source of the food enzyme; ii) manufacturing process of the food enzyme; iii) intended use(s) in food and use level(s) (Proposed normal and maximum levels); iv) dietary exposure assessment;

4) risk management: i) the function and technological need, including a description of the typical process(es) in which the food enzyme may be applied; ii) intended use(s) in food and use level(s) (Proposed normal and maximum use levels); iii) dietary exposure assessment;

5) list of annexes, references and checklist: i) List of references – List of annexes and literature reference; ii) Checklist.

3.4) Previous opinions. Example 2

Another example concerns the evaluation of the glucan 1,4-α-glucosidase enzyme from the genetically modified DP-Nzh38 strain of Trichoderma reesei, where EFSA deemed it unnecessary to conduct the toxicological studies, given the applicant's proposal to use the toxicological data already considered in a previous opinion.

The data supplied by the applicant, the raw materials used and the operations for the production of both enzymes have led EFSA to consider them substantially equivalent. The temperature and pH conditions,
the composition of the TOS were in turn considered comparable, concluding with a favorable overall assessment.

4) Conclusions

A food enzyme already subject to a positive evaluation by EFSA may be the subject of a new application by a subsequent applicant. The application should logically report a modification to the production process of the enzyme or a proposal to extend its use in food processes not already evaluated.

The information to be produced in the new application include some sections of the risk assessment and of the risk management, which depend on the type of application you intend to make. The transparency and confidentiality requirements must comply with the Transparency Regulation and the related general guidelines of EFSA, with attention to the necessary prior notification of studies to be carried out under penalty of their unusability.

The overall scenario remains anomalous and deserves official clarification at European level, taking into account both the objectives of the regulations referred to and the costs required for the compilation and presentation of the relevant dossiers.

Cordially

Dario

Footnotes

(1) Regulation (EC) No 1332/2008 on food enzymes. Consolidated text (12.3.12) http://tinyurl.com/3trbefh6

(2) Commission Regulation (EU) No 234/2011 implementing Regulation (EC) No 1331/2008 establishing a common authorization procedure for food additives, food enzymes and food flavourings. Consolidated text (27.3.21) http://tinyurl.com/2p9e2vyp

(3) EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids), 2021. Scientific Guidance for the submission of dossiers on Food Enzymes. EFSA Journal 2021;19(10):6851, 37 pp https://doi.org/10.2903/j.efsa.2021.6851

(4) Regulation (EU) No 234/2011, Article 2, paragraphs 4,5

(5) See the EFSA guidelines referred to in note 3, part B

(6) EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids). (2023). Food manufacturing processes and technical data used in the exposure assessment of food enzymes. EFSA Journal, 21(7), 1–31 https://doi.org/10.2903/j.efsa.2023.8094



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