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Argentina Reach Regulation for Various Sectors

Argentina has developed national laws and regulations aimed at complying with the country’s obligations towards international agreements such as the Basel, Rotterdam, Stockholm, and Minamata Conventions. Argentina is also a regional leader in the development and implementation of multilateral environmental agreements on chemicals and waste in Latin America. However, the provisions of each convention are managed independently, resulting in a lack of systematic mechanisms to establish cooperation, coordination, and information exchange. To address this, in 2017, the UN Environment Programme (UNEP) had a Special Programme on Institutional Strengthening for Chemicals and Waste Management with Argentina.

In 2018 a draft regulation aimed at developing a comprehensive chemical management was developed by the Argentinian government. The draft National Law for Risk Management of Chemical Substances (Anteproyecto de Ley Nacional para la Gestión del Riesgo de Sustancias Químicas), also known as Bill 4339-D-2019, was finalised in 2019 but is, however, still pending for approval in Congress.

The draft National Law for Risk Management of Chemical Substances would set up rules for manufacturers and importers of chemicals, create a national inventory, collect information on substance identities, require reporting of volume, uses, and information related to hazards and risks. A list of exempted chemicals would also be available, which is expected to cover requirements similar to those of EU-REACH. This regulation is also expected to lead to the creation of a Committee for the Evaluation of Chemical Substances (CESQUI). The bill was first published in July 2019 and a new draft was expected to in 2021. However, it is still unclear when the regulation will be approved by the Government and effectively come into force.

For the prioritization of substances, the Committee for the Evaluation of Chemical Substances (CESQUI) must consider the following:

  • Hazardous properties: persistence, bioaccumulation, toxicity, carcinogenicity, mutagenicity, and reproductive toxicity.
  • Human or environmental exposure: potential level of exposure, quantity of production or import, widespread use deviations that result in harm to health or the environment, exposed vulnerable populations.
  • That the substance is under any international agreement or convention, of which Argentina is party, or that it is included in any international alert pertinent to the field of application of this.
  • That the substance had not gone through a risk assessment process carried out by competent national authorities.

The National Directorate of Hazardous Substances and Waste has the primary responsibility of proposing and implementing actions and management tools regarding hazardous substances throughout their entire life cycle, in order to minimize their adverse effects on human health and the environment. It administers the National Chemicals List and may request information from any Competent Authority, collect information from official sources, and request voluntary contributions from producers, importers, marketers, and users of chemical products, as well as their associations.

The Ministry of Environment and Sustainable Development controls and monitors hazardous chemical management in Argentina. It guarantees the treatment and final disposal of hazardous waste, that moves from one jurisdiction to another, to protect the environment. It is also the authority that will be in charge of the National Law for Risk Management of Chemical Substances once it comes into force.

The Ministry of Labour, Employment and Social Security protects all labour activities in Argentina. Since the implementation of the GHS is workplace oriented in Argentina, this is the entity that supervises its compliance. This public body also works with the Superintendency of Occupational Hazards which is part of the Ministry.

Importers and producers who are dealing with amounts of 1 Tonnes per Annum (TPA) or more in Argentina must comply with the chemical regulations. Argentinian Companies have to comply with the chemical regulations and the GHS related regulations.

Under the draft law Bill 4339-D-2019 importers will have the possibility to designate one or more natural or legal persons established in the national territory as Only Representative (OR) so that the OR can comply with the required obligations for the importers.

According to the draft Bill 4339-D-2019, chemical manufacturers and importers will need to follow following procedures after the Bill comes into force.

Notification under the Preliminary Regime of Bill 4339-D-2019

For the first three years counted from the publication of the Regulation only substances produced or imported in volumes of 1 TPA or more must be notified. Substances of unknown or variable composition (UVCB) must be registered as a single substance. The notification of a substance shall include the following information:

  • Identification data of the producer or importer of the substance

  • Produced amount and annual import of the substance

  • Unequivocal identification of the substance including CAS number when available

  • Content of the Safety Data Sheet according to the GHS, including recommended uses and hazard classification.

Notification under the Definitive Regime of Bill 4339-D-2019

Once the three years of the Preliminary Regime has expired, the notification to the INSQ must be made prior to the beginning the activities of production or importation of the substance in question according to the following procedure:

  • Substances not previously notified: Any substance which is not in the national registries or the INQS must be notified as describe above under the Preliminary Regime and analysis studies and risk assessment of the substance according to the recommended uses must be included.

  • Substances already notified, recommended use not previously notified: Any substance already notified to the INSQ, for which a new recommended use is intended, must be notified including the risk analysis and evaluation studies in accordance with the new use.

  • Substances and uses already notified in advance by a third party: Producers or importers who wish to start production or import activities of a substance already notified by a third party to the INSQ must provide the same information as described for notification under the Preliminary Regime

All information provided must be updated annually when data changes regarding recommended uses, range of volume produced or imported, or hazard classification occur.

There is no information about fees in the draft National Law for Risk Management of Chemical Substances (Bill 439-D-2019).  

The draft National Law for Risk Management of Chemical Substances, Bill 4339-D-2019, defines minor breaches as the failure to update information or repeated provision of incomplete information. This can lead to a fine between 1 and 30 UF (Fixed Unit). Serious non-compliance as provision of false information can lead to the following penalties being applied jointly or separately:

  • Fine between 31 and 700 UF

  • Temporary, partial, or total closure

  • Suspension of the activity from 30 days to one year

  • Suspension of definitive revocation of the qualifications and inscriptions to the corresponding registers.

The Fixed Unit called UF (Unidades Fijas) is created, equivalent to a basic salary of the initial category of the national public administration.

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National Service of Agricultural Food Health and Quality (SENASA), Argentina's pesticide management body, is in charge of pesticide registration oversight. Pesticides are inspected and tested by the national food inspection and quarantine bureau. Argentina's pesticide registration system needs a single registration licence for each pesticide. Furthermore, if a company wants to register a formulation, it must first register technical material. The Plant Protection Act (Law No. 4975) is the principal pesticide regulation.

A phytosanitary product must be registered in the National Register of Plant Therapeutics, either experimentally or commercially, in accordance with the provisions of Decree No 3489/58 and Decree No 5769/59, and in accordance with the Manual of Procedures, Criteria, and Scope for the Registration of Phytosanitary Products in the Argentine Republic, approved by Resolution SAGPYA No 350/99. The Fifth Edition of the MANUAL ON THE DEVELOPMENT AND USE OF FAO SPECIFICATIONS FOR PRODUCTS INTENDED FOR THE PROTECTION OF PLANTS is adopted for Argentina in the Resolution. This is a method of analysing enough scientific evidence to show that a product is useful for its intended purpose and poses no unreasonable dangers to human health or the environment. For product analysis, information on physical, chemical, toxicological, ecotoxicological, and waste properties must come from tests or studies conducted on phytosanitary products to be registered or their equivalents, according to internationally recognised protocols, such as the OECD Guidelines on acute oral toxicity, acute dermal toxicity, inhalation classification, dermal irritation, eye irritation, and skin sensitization.

A phytosanitary product presented to SENASA by a registrant that meets all the requirements set forth in the aforementioned Resolution No 350/99 receives a Certificate of Use and Marketing, allowing the product to be used for all of the purposes for which it was registered, as well as allowing the registrant to market it throughout the National Territory.

​A legal entity might be a person or a firm registered with the Department of Trade and Industry under the Company Act.​

Pesticides are only allowed to be registered if they are approved to be effective, safe, and of high quality.

For oversea manufacturers, they should appoint an Authorized Representative (AR).

To register pesticide it takes 8 days to complete the treatment.

Physical-chemical property determinations in phytosanitary products, phytotoxicity of oils and adjuvants, seed staining tests, and active ingredient identification and quantification assays.

- Typical turnaround time: 8 business days

- Extremely urgent: 5 business days

- Phytotoxicity determination: 15 business days

7-day processing time

Inorganic Contaminant Determination

Typical Time:

7 business days for one analysis

14 business days for two or three analyses

18 business days for more than three analyses

Urgent:

5 business days for one test

Two or three tests: 7 business days
More than three tests: 14 business days

Registration Process

GPC can help you with: 

  • Identification of compliance requirements under various guidelines including all data requirements.​
  • Data gap analysis and pre-assessment support​
  • Technical documentation support​
  • Pre and post-submission support and technical liaison with authorities.

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