Life Sciences Alert – May 2024

Draft Regulation of Law No. 31881, «Law that promotes providing information on gluten-free foods»

By Ministerial Resolution No. 314-2024/MINSA, the draft Regulation of Law No. 31881 was published, «Law that promotes providing information on foods that do not contain gluten» (hereinafter referred to as the Draft Regulation).

The draft regulation aims to regulate the use of «legends» and «symbols» which indicate on labels or in advertising that industrially processed foods do not contain gluten.

The «legends» are all phrases like «gluten-free», «gluten-free» and «no gluten», or their variations in any language that convey the same concept. On the labels, «legends» must «have good highlighting, size and visibility characters» and «may be placed on the main display face of the label or on the back face or on both sides, provided that it does not interfere with the mandatory information on the label, allowing their unambiguously visible and identifiable».

Whereas, the «symbol» is an image of a barred spike. «Symbols» can coexist with «legends», and must «be placed on the main display face of the label and should not interfere with mandatory information on the label, allowing its unambiguously visible and identifiable». On imported foods, other equivalent symbols recognised by the country of origin or accredited certification bodies are permitted.

DIGESA is the competent body to authorize the use of «symbols» for food industrially processed gluten-free domestic or foreign. These authorisations are granted on a product-by-product basis. The authorisation empowers the manufacturer to use this «symbol» on the packaging, container, the packaging or label of the gluten-free food it manufactures for marketing on national territory and, in the case of foreign gluten-free food, It enables its import and marketing in the national territory with the corresponding «symbol». The validity of the health authorization for use of the «symbol» is undetermined and is conditional on the control carried out by DIGESA. In case of non-compliance with the requirements for use of the «symbol» DIGESA has the power to inspect and sanction.

However, the «legend» and the «symbol» can only be used if the authorization of DIGESA is obtained. The authorisation is subject to two key requirements:

• The food comes from manufacturing establishments that have implemented the necessary control measures in the BPM to produce gluten-free foods and have obtained certification of The European Commission has published a report on the health and safety of workers in the Community. The MINSA, subsequently, by Ministerial Resolution, will approve the provisions for the implementation of the BPM Manual for the production of gluten-free foods. In the case of imported food, it is valid to present the BPM certificate issued by the competent authority of the country of origin.
• Laboratory analysis results (valid for 1 year) performed on the finished food which do not exceed the maximum value of 20 mg/kg (ppm) of gluten. The analysis must come from laboratories accredited by INACAL or another accrediting body of a foreign country that has international recognition as signatory to the Recognition Agreement Mutual from ILAC or IAAC.
  The «legend» and «symbol» may not be used in foods that have been fractionated.

It should be mentioned that the production of gluten-free processed foods exclusively for export is governed by the regulations of the country of destination.

The draft regulation states that manufacturers and importers of industrially processed food for marketing purposes are responsible for complying with these standards, which state on the label or in advertising that the food does not contain gluten. The authorities determining the responsibilities and administrative sanctions for non-compliance with the rules of the Regulation are DIGESA (based on the sanctions set out in the Draft Regulation), and INDECOPI (based on the Consumer Protection rules, in case of infringements related to labelling, and the Suppression of Unfair Competition rules, in case of infringement by advertising).

The MINSA will receive suggestions, comments or recommendations regarding the Draft Regulation via the e-mail: webmaster@minsa.gob.pe, during the period of ninety (90) calendar days expiring on 8 August 2024.