To implement Peru's national chemical law, the Peruvian government published a draft regulation on the classification, reporting, and prioritization of hazardous substances in late July, aimed at strengthening the management of chemicals. This draft will enforce Decree No. 1570 issued last year, which established the framework for a chemical management system and set up the National Registry of Chemical Substances (RENASQ).
Under the draft, manufacturers and importers are required to register hazardous substances according to the sixth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The draft includes a "predicted chemical hazard classification" list of over 4,400 substances, with different registration timelines depending on whether the substance matches the classification in the "predicted list." Here is a detailed analysis of the key points of this draft, including the registration system, chemical labeling, Safety Data Sheets (SDS), and exemptions.
Separated Registration System
The Ministry of Health (MINSA) is responsible for entering GHS hazard classification, SDS, and label information into the RENASQ system. These substances were previously handled by health institutions, such as registered active ingredients in pesticides.
The Ministry of Environment (MINAM) is responsible for registering substances not yet processed (submitted by manufacturers and importers).
Manufacturers and importers must submit their GHS hazard classification, SDS, and labels to MINAM for approval. Information required for registration includes:
- Details of the manufacturer or importer and suppliers;
- Chemical identification information, including nomenclature by the International Union of Pure and Applied Chemistry (IUPAC) and CAS number (if available);
- Recommended uses;
- Quantity manufactured or imported
Chemical Labeling
All label information for domestically produced or imported chemicals must be written in Spanish. Manufacturers and importers may optionally add translations in other languages.
Manufacturers, importers, distributors, and sellers must ensure the readability of all information on the labels. The size of the label should be proportional to the size and shape of the container containing the chemicals, with specific dimensions as follows:
| Container capacity (liters) | Label size (mm) | Graphic size (mm) |
| ＜ 3 | ≥52 x 74 (if possible) | ≥10 x 10 (ideally ≥16 x 16) |
| 3 ≤ container capacity ≤ 50 | ≥74 x 105 | ≥23 x 23 |
| 50 ≤ container capacity ≤ 500 | ≥105 x 148 | ≥32 x 32 |
| > 500 | ≥148 x 210 | ≥46 x 46 |
- Even chemicals classified as non-hazardous should have at least one precautionary statement on the label. The choice of precautionary statements should be based on Annex 3 of the GHS, or new suggestions can be added based on the judgment of the person responsible for labeling.
- Labels ay contain supplementary information as long as it does not hinder, delay, or contradict the requirements of the GHS or this regulation. Additionally, the use of NFPA (National Fire Protection Association) symbols on labels is prohibited, as they do not meet the requirements of the GHS and can only be included in Section 16 "Additional Information" of the SDS or usage points.
- Chemical labels must appear on all movable containers, including those used for transfer.
- For high-mobility temporary containers (e.g., containers used for sampling), the label on the container should at least include hazard pictograms and signal words. In these cases, the full label should be located at the point of use of the container and be easily accessible.
- For fixed tanks, the label should at least include hazard pictograms and signal words, and the fixed tank should be considered simple packaging for transport. In these cases, the full label should be located at the entrance to the spill containment pool, with dimensions that meet the requirements for containers over 500 liters.
- For small containers, the label should at least comply with the guidelines contained in Example 8 of Annex 7 of the GHS.
Safety Data Sheets (SDS)
- The preparation of the SDS must comply with Annex 4 of the GHS.
- Data on the chemical hazard classification of the chemical should be included in the relevant section of the SDS.
- Regardless of the source, the SDS for chemicals must be presented in Spanish. Manufacturers and importers may optionally add translations in other languages.
- The version number and date of issue of the SDS should be displayed on the front page. Additionally, the SDS should be easily accessible at the point of use of the chemical.
- Manufacturers or importers should provide the SDS free of charge, preferably in digital format, and include the chemical name clearly visible on each page, as used on the label.
Exemption Regulations
According to Section 3.2 of Decree No. 1570, the following chemical substances are not covered by this supreme decree:
- Samples with no commercial value mentioned in Section 3.2(d) of Decree No. 1570, which are used to demonstrate their properties rather than for domestic sales, and thus are used for the aforementioned tests or demonstrations. Under the current tariff system, these are equivalent to "samples of negligible commercial value." Pure chemical substances are not considered samples with no commercial value.
- Unintentional chemical reaction products mentioned in Section 3.2(e) of Decree No. 1570, which are produced due to accidents or unintentional contact with environmental factors (such as air, humidity, microorganisms, sunlight, or other relevant factors).
- Impurities mentioned in Section 3.2(h) of Decree No. 1570, which are considered impurities when they do not exceed certain hazard category cutoff values or concentration limits.
- Substances contained in articles mentioned in Section 3.2(h) of Decree No. 1570, which do not release chemicals under normal use conditions, do not lead to exposure to these substances, and are not intentionally released from articles.
- Exclusions mentioned in Sections 3.2(k), (l), and (m) of Decree No. 1570, which do not include chemicals used as production inputs.
Registration Deadlines
- Substances on the predicted list: Substances in the predicted chemical hazard classification list need to be registered within one year.
- Substances with differences: If a substance is on the list but the classification differs, it needs to be registered within 18 months.
- Non-hazardous or unlisted substances: For non-hazardous or substances not listed in the predicted list, registration is required within two years.
- New substances: For new substances not registered in the RENASQ system, registration is required within three years.
The introduction of this draft marks an important step forward in chemical management in Peru. Through these regulations, Peru aims to protect public health and environmental safety, while promoting the sustainable development of the chemical industry. For manufacturers and importers, understanding and complying with these new regulations is key to ensuring compliance. The public and relevant stakeholders can submit comments and suggestions on the draft until October 24.
