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On July 24, 2024, Peru's Ministry of the Environment (MINAM) published its draft REACH-inspired Regulation, namely Supreme Decree N° xxxx -2024-MINAM (hereinafter referred to as the Supreme Decree) under the Ministerial Resolution No. 00214-2024-MINAM for public consultation. Opinions must be submitted to MINAM within 10 business days from the date of publication.
Background
On May 28, 2023, MINAM approved the chemical registration legislation (Legislative Decree No. 1570) and published it on the Official Gazette, which establishes the registration requirement for the National Registry of Chemical Substances (RENASQ) and a process for risk assessment of priority substance. (Read more). However, the detailed requirement on GHS implementation and REACH-inspired process are left to be addressed by the subsequent Supreme Decree .
The Law on the Comprehensive Management of Chemical Substances (GISQ Law) establishes that Decree No.1570 must be approved by Supreme Decree at the proposal of MINAM and endorsed by the heads of the competent sectors, within a period of no more than one year.
In this context, MINAM prepared the draft supreme decree that approves the regulations of the GISQ Law, whose technical grounds justifying its approval.
GHS Implementation
Under the framework of Legislative Decree No. 1570 and the Supreme Decree, Peru adopts GHS Rev.6 (2015) as the basis for hazard classification, label and SDS.
Manufacturers and importers are responsible for the hazard classification of chemical substances. A prelist of hazard classification of 4,404 chemical substances are provided in Appendix 1 for reference. This list will be updated every 2 years by MINAM.
It should be noted that all GHS classes and categories are within the scope except the Category 5 Acute Toxicity.
The chemical labels shall be written in Spanish. All manufacturers, importers, distributors and marketers shall ensure the legibility of all information contained on the label. The label size is proportional to the size and shape of the container as indicated below:
| Container capacity | Label dimension (in mm) | Pictogram dimension (in mm) |
| ≤3L | At least 52*74 (if applicable) | At least 10*10 (ideally, at least 16*16) |
| ＞3L and ≤50L | At least 74*105 | At least 23*23 |
| ＞50L and ≤ 500L | At least 105*148 | At least 32*32 |
| ＞ 500L | At least 148*210 | At least 46*46 |
In the case of small containers, the label must at least comply with Example 8 in the Annex 7 of the GHS.
Manufacturer and importer is also responsible for the preparation of SDS, which shall be performed in accordance with Annex 4 of GHS. The SDS is also obligatorily written in Spanish. The version number and issuance date of SDS must be reflected on the first page.
Evaluation
The Supreme Decree establishes an evaluation process on the hazard classification, label and SDS of chemical substances, which will be progressively carried out by MINAM to the following batches of chemical substances manufacturerd or imported in Peru:
1st batch: MINAM to evaluate the prelist of chemical substances 1 year after the Supreme Decree takes effect;
2nd batch: MINAM to evaluate chemical substances with different classifications from the established prelist of chemical substances 1.5 years after the Supreme Decree takes effect;
3rd batch: MINAM to evaluate chemical substances that are not on the aforementioned list; and non-hazardous chemical substances 2 years after the Supreme Decree takes effect;
4th batch: MINAM to evaluate chemical substances that are not previously submitted for evaluation prior to their commercialization 3 years after the Supreme Decree takes effect.
Prioritization
Since the 3rd year of entry into force of this Supreme Decree, MINAM will commence the prioritization of chemical substances based on information registered in RENASQ.
After 4 years of approval of this Supreme Decree, MINAM will publish a list of priority chemicals subject to the presentation of risk assessments for health and the environment. Manufacturers or importers of the listed chemical substances are required to prepare and submit risk assessment files to the Ministry of Health (MINSA) for approval.
Prohibition or Restriction
The prohibition or restriction of the manufacture, import or use of hazardous substances will be carried out based on the information contained in RENASQ, risk assessment results, scientific evidence, international agreements, international standards, or updated information available from reliable sources of information.
Reporting
Manufacturers and importers of chemical substances determined as hazardous are required to report to RENASQ the manufactured or imported quantities before February 15 each year. This obligation shall be effective starting from 3 years after the Supreme Decree takes effect.
The importers of mixtures need to submit the additional information as follows:
Name, including the commercial name, IUPAC nomenclature and CAS number, when applicable.
Recommended use(s).
Hazard classification.
Annual quantities corresponding to the previous year.
In case a hazardous substance is prohibited or restricted from its manufacture, import or use, the mixtures containing these hazardous substances shall be reported to RENASQ.
The Supreme Decree can be accessed here.
