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The Brazilian REACH regulation is coming! Chemical exports to Brazil must see!


Time:

2022-12-07

On November 23, 2022, the Committee on Economic Development, Industry, Commerce and Services (CDEICS) of the Brazilian Chamber of Deputies had approved Act 6120/2019 and submitted it to the Committee on Constitution, Justice and Citizenship (CCJS) for further approval. If approved, the Chemicals Act will become the Brazilian version of REACH regulations.

On November 23, 2022, the Committee on Economic Development, Industry, Commerce and Services (CDEICS) of the Brazilian Chamber of Deputies had approved Act 6120/2019 and submitted it to the Committee on Constitution, Justice and Citizenship (CCJS) for further approval. If approved, the Chemical Act will become the Brazilian version of REACH regulations, and domestic enterprises exporting chemicals to Brazil need to pay close attention!

The bill mentions that Brazil will establish a unified list of chemical substances, screen a batch of priority chemicals and carry out risk assessment on them, screen a batch of chemical substances that need authorization, and specify the law enforcement agencies responsible for chemical management. If the bill is approved and raised to law, Brazil will become the third country in South America to establish chemical management regulations after Chile and Colombia.

 

Exemption
I - Radioactive material;
II - Chemical substances being developed or specially used for research, and the quantity in compliance with regulations;
III-Individable intermediates, impurities, pollutants and chemicals generated by unintentional reactions, including those generated during storage or due to environmental factors;
IV - Chemical substances, mixtures and articles under customs control, which are temporarily stored in free zones or free warehouses for re export or transit;
V - Narcotic drugs, psychotropic drugs and immunosuppressants prescribed by specific laws;
VI - Substances specially used as tobacco components and derivatives;
VII - Plates, sheets, strips, billets, ingots, beams and other similar forms of metal alloys and metals used for structural purposes;
VIII - Explosives and accessories;
IX - Waste;
X - The following products subject to specific laws:
(a) Pesticides and related products, premixes and technical products;
(b) Drugs and medical gases;
(c) Cosmetics, toiletries and perfume;
(d) Disinfectant;
(e) Veterinary products;
(f) Manufacturing technology of food, food additives and auxiliary materials;
(g) Products used for animal feed;
(h) Fertilizers, inoculants and correctives;
(i) Wood preservatives;
(j) Environmental remediation agent.
XI - The following substances, in accordance with the standards and requirements of the Globally Harmonized System of Classification and Labelling of Chemical Substances (GHS), are excluded from substances that have been chemically modified or are composed of or contain substances harmful to health or the environment:
(a) Ore and its concentrate, as well as other rocks and minerals, including coal and coke, crude oil, natural gas, liquefied petroleum gas, natural gas condensate, gas and components of mineral production process;
(b) Natural substances;
(c) Fat, essential oil and fixed oil extracted by grinding, pressing or bleeding, even if they are purified, as long as their products have the same characteristics as the original products;
(d) Glass, ceramics.

 

Declaration of chemical substances
Mixtures and polymers of low concern do not need to be declared for chemical substances. Non low concern polymers need to be addressed. The chemical substances produced or used in Brazil and stored in excess of 1t/a (average value in the past three years) need to submit a chemical substance declaration to establish a chemical substance list. The information requirements for declaration include
I - Information of the manufacturer or importer specified in the regulations;
II - Identification of the chemical according to the name and CAS registration number (if any) of the Chemical Abstracts Agency (CAS) or the International Union of Pure and Applied Chemistry (IUPAC);
III - Annual production or import quantity range;
IV - Recommended use of chemicals;
V - Hazard classification, according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), according to current Brazilian standards.
In case of any change in the above information, the change information shall be submitted before March 31 of the next year.
Registration of new chemical substances
Once the list of chemical substances is determined, those not included in the list are new substances. The production or use of new substances requires submission of new substance registration documents and risk assessment of new substances. At present, the specific data requirements have not been determined.

 

Priority chemical screening criteria
I - Persistent and environmental toxicity;
II - Bioaccumulation and toxicity to the environment;
III-Persistence, bioaccumulation and toxicity to the environment;
IV carcinogenicity, mutagenicity or reproductive toxicity;
V - Characteristics of endocrine disruptors based on scientific evidence;
VI - Equal hazard to human or environmental exposure;
VII - Substances in agreements or international conventions signed by Brazil.
It is worth noting that the bill mentions that overseas chemical producers are allowed to entrust a sole representative (OR) to fulfill their regulatory obligations.
According to the statistics released by the Brazilian Chemical Industry Association, from June last year to May this year, Brazil's total chemical trade imports reached 71.4 billion US dollars, up 16.5% year on year; The total export of chemicals was 16.4 billion US dollars, up 13.4% year on year. The chemical trade deficit reached 55 billion US dollars in 12 months, a record high.

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