Argentina Regulatory News

On 2 November 2023, the 90-day deadline set by the Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) for companies to make the required revisions and begin the proce...

On 2 November 2023, the 90-day deadline set by the Argentine National Administration of Medicines, Food, and Medical Technology (ANMAT) for companies to make the required revisions and begin the process of changing formulations and labeling required under Provision 5978 / 2023 will expire.

The Provision was released by the ANMAT on 4 August 2023. The article prohibits the use of certain substances in cosmetics, personal hygiene, and perfume products, including 4-Amino-3-hydroxytoluene, 1,2,4-Trihydroxybenzene, and 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid.

The EU’s Scientific Committee on Consumer Safety (SCCS) has already issued opinions on the safety of these ingredients when used in hair and eyelash dyes. The SCCS found that 4-amino-3-hydroxytoluene and 1,2,4-Trihydroxybenzene are genotoxic, while 2-[(4-amino-2-nitrophenyl)-amino]-benzoic acid is mutagenic. According to the findings, the use of these chemicals in cosmetics is not safe. Based on the quality of the scientific evidence provided, the European Commission modified Annex II of Regulation No. 1223/2009 to include these compounds in the list of substances restricted for use in cosmetics. ANMAT cites the EU's findings as the proof required to ban the chemicals in Argentina.

Provision 5978 / 2023 also forbids the marketing of cosmetic products containing these chemicals. Companies that own, produce, or import cosmetic items affected by this clause have 90 calendar days (until 2 November 2023) to make required revisions and commence the process of changing formulations and labeling. Penalties for non-compliance will be imposed in accordance with Law 6.463 and Decree No. 341/92. The Provision entered into force on the day of its publication in the Official Gazette, and it must be filed with the National Directorate of the Official Registry, the Argentine Chamber of the Industry of Personal Hygiene, Cosmetics, and Perfumery Products, and other organizations.

Argentina has introduced fresh technical guidelines for the storage of mercury in line with the Minamata Convention. The issued Resolution delineates the particulars concerning storage and management,...

Argentina has introduced fresh technical guidelines for the storage of mercury in line with the Minamata Convention. The issued Resolution delineates the particulars concerning storage and management, encompassing explicit stipulations for labeling. These updated regulations are applicable to any entity or individual within Argentina who is in possession of mercury under the following conditions:

Those who have sought exemption in accordance with Resolution MAyDS No. 299/21;

Those who have had their Reconversion Plans approved under the Minamata Convention on Mercury as per Resolution MAyDS No. 503/22;

Those subject to the provisions of Law No. 24,051. 

The Argentinian government has published the fees for registration, importation, notification, fines and tariffs for 2023 regarding the Registry of Chemical Precursors created by Law 26.045 of 8 June ...

The Argentinian government has published the fees for registration, importation, notification, fines and tariffs for 2023 regarding the Registry of Chemical Precursors created by Law 26.045 of 8 June 2005. The fees are summarized in the following table: 

To make the payment there are several options available. The first option is to make a transfer or deposit that corresponds to the fee that needs to be paid or the value of the tariff that is required for the compensation of tariffs that were acquired before the Resolution 647/2021 of 30 December 2019 (Procedures within the National Registry of Chemical Precursors) came into effect. 

Another option is to complete the form found on the website www.entecooperador.org.ar/informar-pago.html. Once the payment has been made, it is necessary to wait for the receipt of an electronic invoice, which will be emailed within 48 hours of the next business day after the transfer or deposit was made. 

If the invoice has not been received after 72 business hours, it is important to inform the National Registry to the email: pedidos@entecooperador.org.ar. 

On September 29, 2022, Argentina enacted Provision 7809/2022 which puts in force the MERCOSUR Technical Regulation on labelling for personal hygiene products, cosmetics and perfumes. This is a step to...

On September 29, 2022, Argentina enacted Provision 7809/2022 which puts in force the MERCOSUR Technical Regulation on labelling for personal hygiene products, cosmetics and perfumes. This is a step towards the uniformization of technical requirements for cosmetics and personal care products in Argentina, Brazil, Paraguay, and Uruguay. This regulation establishes the essential information that must be included on the labels of personal hygiene products, cosmetics, and perfumes regarding their use, as well as any necessary indication regarding the products. 

Cosmetic and personal care products must comply with this requirement within 36 months from the mentioned date.  This means that importers, manufacturers and others will have to finalize their product registration until September 29, 2025. This regulation states general labelling requirements for personal hygiene products, cosmetics and perfumes which entails minimum mandatory data depending on the type of container used. It also indicates specific requirements for: 

• Aerosols 

• Neutralizers, waving and straightening products 

• Hair lightening agents and hair dyes 

• Bleaching agents for hair/body hair 

• Dye for hair/body hair 

• Depilatories and epilatories 

• Toothpaste and mouthwashes with fluoride 

• Antiperspirant products 

• Tonics/hair lotions 

• Activators/cccelerators of tanning 

• Self-Tanners/tan Simulators 

• Oral care products suitable for sensitive teeth 

• Products for intimate hygiene 

• Hypoallergenic products 

MERCOSUR, also known as the Southern Common Market, is an international integration body where Argentina, Brazil, Paraguay and Uruguay are full members. Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Surinam are associated countries. Bolivia is currently undergoing an adherence process to join MERCOSUR.  

The Argentinian government adopted, on 22 August, 2022, new Mercosur rules concerning the inland transport of dangerous goods, covering both road and rail transport.    Currently, the transpor...

The Argentinian government adopted, on 22 August, 2022, new Mercosur rules concerning the inland transport of dangerous goods, covering both road and rail transport. 

Currently, the transport of dangerous goods in and between Mercosur countries (Argentina, Brazil, Paraguay and Uruguay) is regulated by a series of agreements established starting in 1994 (Mercosur Decisions 2/94, 14/94, 32/07 and 19/09). While maintaining the overall system, new rules introduced by Decision 15/19 will adapt it to align with changes in other global and international regulatory frameworks. 

Mercosur rules must be adopted individually by Member States, and become applicable once they have been ratified by all of them. While the initial deadline for adoption by Member States was July 1, 2020, only Uruguay and Argentina have completed their domestic transposition process. 
 

Chemical policies are rapidly developing in Latin America. National Chemical Regulations are the main focus of regional cooperations as well as projects initiated by international organizations. A num...

Chemical policies are rapidly developing in Latin America. National Chemical Regulations are the main focus of regional cooperations as well as projects initiated by international organizations. A number of countries have been drafting chemical management frameworks. Countries like Brazil, Chile and Colombia are taking a step further to put these regulations in place. Here is the summary of what you should expect for compliance requirements in Latin America in 2022:

• Argentina is expected to publish a more comprehensive and revised draft regulation since the last draft version dates from September 2019.
• Brazil progressed with its chemical regulatory law in December 2021 when the Deputies’ House Environmental Commission approved the bill. The draft still must be approved by another three in-house commissions after formal sanction.
• Colombia is the most recent country to enact its chemical management in November 2021. Colombia will likely announce its National Inventory in May/June 2022.
• Costa Rica has been involved in several meetings for technical and operational discussions involving chemical administration. Costa Rica is focusing on first implementing the Registry of Releases and Transfers of Pollutants (RETC in Spanish).
• Chile, the first country in Latin America to adopt a solid framework for chemicals, is waiting to publish the risk assessment criteria and guidelines to drive chemicals prioritization. The National Inventory only comes in 2025.
• Peru's single regulatory draft bill was submitted for public comments in September 2020, which is still under process. However, the country has been moving closer to OECD membership, signaling a resumption of activities.