What is the purpose of the Regulations?
The purpose of the Regulations is to regulate and supervise the sanitary control of hazardous substances for domestic, industrial and/or public health use established in Chapter VI of Title II of Law No. 26842, General Health Law.
The Regulations will be enforced by the General Directorate of Environmental Health and Food Safety (DIGESA) of the Ministry of Health.
To whom do they apply?
The Regulations apply to natural and legal persons that carry out activities related to the importation, manufacture, formulation, processing, assembly, distribution, commercialization, storage, use, handling and destruction of hazardous substances for domestic, industrial and/or public health use.
The Regulations include the following provisions:
- New classification of products in the manufacture of which hazardous substances are used
Formulated products whose manufacture includes the use of hazardous substances for domestic, industrial and/or public health use are classified as follows:
- Chemical products for industrial use
- Inert surface disinfectant products for domestic, industrial and/or public health use, and disinfectant products for swimming pool water
- Pesticide products for domestic, industrial and/or public health use
- Hazardous products under the Rotterdam Convention
Each product classification has its own requirements and administrative procedures for the respective sanitary authorization to be issued.
- General aspects of the sanitary authorization
These products require prior authorization from the state (in this case, through DIGESA) to be marketed and used safely without affecting people's health or the environment.
The most important elements of the procedure for the corresponding authorizations to be issued are the following:
| Category |
Regulated activities |
Maximum term to issue the sanitary authorization |
Term of authorization |
Renewal |
- Industrial chemicals
- Disinfectants for domestic, industrial and commercial use
- Pesticides for domestic and industrial use for commercial purposes
|
Manufacture, importation, distribution, sale and storage |
30 working days if no questions, issues or objections are raised by the administration |
Three years |
There is a requirement to maintain the quality, safety and efficacy characteristics.
It will be valid for three additional years.
It must be filed 60 working days prior to the expiration.
The maximum term to issue the renewal is 20 working days if no questions, issues or objections are raised by the administration
|
- Imported industrial disinfectants or pesticides that are not for commercial use
|
Importation with the purpose of being used in research or marketing studies or for the applicant's own use, and not for commercial use |
20 working days if no questions, issues or objections are raised by the administration |
Only to import the requested quantity |
None |
- Hazardous products under the Rotterdam Convention
|
Only the entry into the country for commercialization or use |
20 working days if no questions, issues or objections are raised by the administration |
One year |
None |
- Product packaging or labeling
The packaging must contain the product information in accordance with the nationally adopted version of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
Regarding the labeling of these products, their primary or secondary packaging must contain legible information in accordance with the GHS and in Spanish. Finally, the Regulations state the minimum information that these products must contain.
The name of the products must not cause confusion about their composition, properties or indications.
- Extension and/or modification of sanitary authorizations
The Regulations allow, under the same quality and safety conditions, (i) the modification of fragrances and/or colorants of the authorized products, and (ii) the extension of the product's scope with respect to other microorganisms or pests different from those authorized for the following products:
- National or imported disinfectants for domestic, industrial and/or public health use for commercial purposes
- National or imported pesticides for domestic, industrial and/or public health use for commercial purposes
- Revocation, cancellation of the sanitary authorization and stockout
- Revocation: The sanitary authorization will be revoked when it is determined that the hazardous substances for domestic, industrial and/or public health use are unsafe or ineffective according to the terms under which they were authorized, or that they may affect the health of the population, based on information issued by the WHO, regulatory authorities of other countries or control and sanitary surveillance actions.
- Cancellation: The holder of the sanitary authorization may request the cancellation of the authorization, being responsible for the collection of the marketed product and its use after cancellation.
- Stockout: It can be applied when the holder of the sanitary authorization makes modifications or when the validity of the sanitary authorization has expired and provided that the product has no observations regarding its quality or sanitary safety and there are still products in the market.
- Prohibitions
| On activities related to hazardous substances of domestic, industrial and/or public health use |
On finished products containing hazardous substances of domestic, industrial and/or public health use |
| Manufacture in premises intended for housing, food markets, commercial galleries, shopping centers and fairs |
Use of carcinogenic, teratogenic, mutagenic or other harmful substances in the manufacture, importation, distribution, commercialization or storage of the products, as required by the WHO, IARC, ECHA and other international agencies |
| Manufacture, storage and commercialization in the same environment where food, beverages and/or medicines for human use are manufactured, prepared, stored, assembled or sold |
Domestic use of pesticides classified in acute toxicity hazard categories 1, 2 or 3, according to the GHS |
| Industrial and/or public health use of pesticides classified in acute toxicity hazard categories 1 or 2, according to the GHS |
| Domestic use of disinfectants classified in acute toxicity hazard categories 1, 2 or 3, according to the GHS |
| Industrial or public health use of disinfectants classified in acute toxicity hazard categories 1 or 2, according to the GHS |
| Importation, manufacture, distribution, storage, commercialization and assembly of products manufactured with hazardous substances for domestic, industrial and/or public health use that contain in their formulation substances listed in Annex A of the Stockholm Convention on Persistent Organic Pollutants |
| Importation, manufacture, distribution, commercialization or assembly of products whose formulation contains substances listed in Annex III of the Rotterdam Convention |
| Importation, manufacture, distribution, commercialization, storage and assembly of products manufactured with hazardous substances for domestic, industrial and/or public health use whose formulation contains mercury or mercury compounds that contravene the provisions of the Minamata Convention on Mercury |
- Control of these products
DIGESA supervises establishments intending to import, manufacture, formulate, process, assemble, commercialize, distribute and store hazardous substances for domestic, industrial and/or public health use, to verify that they comply with the requirements established in the Regulations.
Likewise, DIGESA may take samples from the aforementioned establishments to verify that they comply with the technical specifications stated to obtain the sanitary authorization.
- Violations and penalties
DIGESA is the authority in charge of exercising the sanctioning power with nationwide jurisdiction.
Violations are provided in the Regulations and refer to the noncompliance with prohibitions, obligations and labeling. Those who incur in the infractions typified in the Regulations will be subject to the following penalties:
- Warning
- Temporary or definitive closing of the establishment
- Cancellation of the license
- Fines between 0.5 and 100 tax units
We hope this information is of relevance to you and your company. Please do not hesitate to contact us if you require any advice in this regard.
Spanish version
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