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Life Sciences Alert – January 2025

ALERT – LIFE SCIENCES

Draft Regulations on Labeling of Genetically Modified Foods

According to Article 37 of the Consumer Protection and Defense Code (hereinafter the Code), packaged foods containing genetically modified ingredients must indicate this on their labels.

Although to date there is no specific regulation on the way in which these components should be communicated on labels, INDECOPI has interpreted that no specific regulation is required and that the presence of genetically modified ingredients should always be reported on the product labeling, by virtue of Articles 4.1 and 4.2 of the “General Standard for the Labeling of Prepackaged Foods” (CXS 1-1985) of the Codex Alimentarius.

With the intention of regulating this type of products and in compliance with the provisions of the Third Final Complementary Provision of the Code, which orders INDECOPI to regulate Article 37, on January 23, 2025, Ministerial Resolution No. 010-2025-PCM was published, through which the “Draft Supreme Decree approving the Technical Regulations on Labeling of Genetically Modified Foods” (hereinafter the Draft) was published.

According to the Draft, it will be mandatory to include in the labeling the phrase “Genetically Modified Food” or “GM Food”, indelibly or through the use of an adhesive, when the following assumptions are met in packaged foods:

(i) They are available to final consumers at points of sale in the national territory or are intended for catering purposes (for use in restaurants, canteens, schools, hospitals and similar institutions where meals are prepared for immediate consumption);

(ii) They are included in the list in Annex 1; and,

(iii) The percentage of genetically modified components or ingredients exceeds the tolerance threshold of 3%.

To determine whether the product exceeds the 3% tolerance threshold for genetically modified ingredients, or to demonstrate that the threshold is not exceeded, a test report issued by INACAL accredited testing laboratories (see NTP-ISO 24276:2016 and NTP 731.001:2018) or to an accreditation body of another country that is a signatory to the ILAC Mutual Recognition Arrangement or the IAAC Multilateral Recognition Arrangement must be completed. Note that INDECOPI will have the power to require products, manufacturers or importers to support the veracity of the information contained in the labeling.

The Draft proposes that the obligors may take advantage of the “EXHAUSTION OF STOCK” for a maximum period of twelve (12) months, only if they communicate it to DIGESA within thirty (30) working days following the entry into force of the Regulation.

It is proposed that the Regulation becomes effective six (6) months after its publication and, once published, the obligors will have a period of one (1) year to comply with it.

Finally, we must mention that this is a Draft subject to review and there is a period of ninety (90) calendar days for INDECOPI to receive comments, contributions or opinions from public and/or private entities and citizens in general.

The annex can be accessed at the following link


For further information, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and Ricardo de Vettor (rdevettor@estudiorodrigo.com).