In
2018, a memorandum of understanding and
cooperation for the management of chemicals was signed between Argentina and
Brazil. Among its objectives, the memorandum aimed to exchange information
(including the Brazilian study on chemical management) and to strengthen
collaboration in the design of policies, regulations, and regulatory
instruments for the management of chemical substances.
The
National Law for the Management
of the Risk of Chemical Substances was published in June 2019 with
the purpose to create a harmonized inventory at the national level of all
chemical substances produced or introduced in the territory and to strengthen
the mechanisms for evaluating and managing their risk. The system is similar to
the one proposed in Brazil: it will be implemented in phases; the Ministry of Environment
and Sustainable Development is the main agency in charge; chemicals will be
evaluated by a special committee that will create a hazardous chemical list
(and will be prioritized for risk management); a 3 years adaptation time; and
manufacturers’ and importers’ mandatory annual updates to the system will
follow.
The
local government issued Resolution 192/2019, which created a
national list of existing, restricted, and prohibited chemical substances, and
is continuously being populated. Moreover, Decree 504/2019 was closely
published, implementing an interministerial group responsible for coordinating
different governmental areas to guarantee national management of chemical
substances, fulfilling the national and international commitments assumed.
The
draft law of national chemical legislation was presented to public discussion
in September 2019, right before the country’s election in October. In the end,
the change in government affected further progress and the draft was withdrawn
by Argentina’s executive power. Meanwhile, an improved version is ready to be
published, but not to be presented to Congress since the new election is
scheduled for October 2021.
|
Country |
Argentina |
|
National Regulation |
|
|
Status |
Draft |
|
Regulation name |
Draft National Law
for the management of the risk of chemical substances Anteproyecto de Ley Nacional para la gestión del riesgo de sustancias
químicas - link |
|
Objective |
Establish a
harmonized inventory at the national level for all chemical substances
produced or introduced into the country, as well as the definition or
strengthening of risk assessment and management mechanisms |
|
Scope |
Imported or
manufactured substances, including mixtures |
|
Further substance lists |
There is no further
list of substances of concern on the current draft. A separate list is
available here. |
|
Exemption |
Substances intended
for research, radioactive, residues, on transit or warehouse, unintended,
used in medicines or food additives, and natural substances |
|
Affected stakeholders |
Importers and
producers when dealing with amounts ≥ 1 ton per year |
|
Requirements |
It is required to
provide the following information:
|
|
Non-compliance |
Sanctions’
modalities:
|
|
Comments |
A new draft version
is expected to come out in 2021 defining:
The new draft is to
be presented to Congress later in October 2021, after national elections |
Adoption of GHS
Argentina
officially adopted GHS 5th version in 2017 through Resolution 801/2015, which was amended
twice by Resolution 3.359/2015 and Resolution 155/2016. Altogether, GHS
became mandatory for substances on January 1st, 2017, and for mixture from June
1st, 2017. In Argentina, the GHS is supplemented by the Argentine Institute of
Standardization and Certification (IRAM) norms 41.400/2013 (SDS) and IRAM 41.401/2020 (Labels).
SDS
/ GHS Regulation |
|
|
Status |
In place (GHS 5th
version) |
|
Regulation name |
Legislations:
Standards:
|
|
Implementation date |
Workplace:
Transport:
|
|
Language |
Spanish |
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.
