Brazilian Legislative Draft on Industrial Chemicals

Brazil does not currently have a Reach-like regulation of new chemical substance notification requirements for industrial chemicals. While Brazil is developing its own national substance inventory, the following is a summary of its efforts to create one:

Brazil has specific regulations for pharmaceuticals, cosmetics, pesticides, sanitizing products and explosives, but as yet there are no regulations that apply for industrial chemicals.

In October 2018 Brazil started to create its substance inventory and new chemical management policy. The National Chemicals Safety Commission (Comitê Nacional Sobre Segurança Química, or CONASQ), along with the Ministry of Environment (Ministério do Meio Ambiente, or MME), published a Preliminary Bill for the Inventory, Evaluation, and Control of Chemical Substances.

The draft provisions are set on the creation of an existing national chemical substance inventory and the evaluation and control of chemical substances. The draft also makes GHS mandatory for industrial chemicals in the workplace.

The draft law mainly applies to an amount greater than or equal to 1 ton per year (>=1t/y) of industrial chemical substances. According to article 3 of the draft, the following chemical substances are out of scope.

  • Radioactive substances
  • Substances in development or solely for research
  • Non-isolated intermediates
  • Narcotic and psychotropic substances
  • Pharmaceuticals
  • Agrochemicals
  • Cosmetics and personal hygiene products
  • Food and food additives
  • National Inventory of Chemical Substances

Articles  6 and 7 of the legislative draft requires producers or importers of industrial chemical substances, including substances in mixtures, in an amount equal to or greater than 1 ton per year (>=1t/y) based on three years’ average, to submit the following information to the National Register of Chemical Substances maintained by CONASQ.  All substances gathered will be used to build the National Inventory of Chemical Substances in Brazil.


The following is also required:

Company identification of producer or importer;
Substance identity such as CAS name or IUPAC name and CAS number if available;
Quantity produced or imported per year;
Recommended uses;
GHS classification

The expected deadline to submit the above will be three (3) years from the availability of a substance.

New Substance Registration

Once the existing national chemical substance inventory has been finalized, chemical substances which are not listed will be regarded as new chemical substances.

Manufacturers and importers of greater than or equal to 1 ton (>=1t/y) per year of new chemical substances need to register those new substances by submitting additional studies and risk assessment report. Data requirements will increase with tonnage bands.

Certain existing chemical substances on the inventory will be selected for Evaluation

New substances and certain existing industrial chemicals on the inventory will be selected for hazard evaluation by an Industrial Chemicals Assessment Technical Committee if they meet the following criteria: Persistent, bio-accumulative or toxic to the environment; or Carcinogenic, mutagenic or toxic to reproduction; or Endocrine disruptors, based on scientific evidence; There are relevant potential exposure to humans and the environment; Controlled by international treaties or conventions of which Brazil is a member or signatory.

Note:Industrial chemical substances which do not fulfill one or more of the criteria above but may give rise to a level of equivalent concern may also be subject to evaluation. Producers and importers of greater than or equal to 1 ton per year of (>=1t/y) of industrial chemicals subject to evaluation will be required to submit certain information, studies, and safety data sheets to CONASQ to support risk assessment. Depending on the results of risk assessment, CONASQ may prohibit or restrict the production, import, trade or use of certain chemical substances. For additional information, visit: http://www.mma.gov.br/seguranca-quimica.html

Brazil is planning a national policy on industrial chemicals. The country intends to conclude the draft by the end of the year, and then it will be presented to the National Congress.

The proposed law, which includes a proposal to create a chemicals inventory, will list the obligations, mechanisms and institutional arrangements to meet the policy’s goals. These will include establishing a national chemicals inventory using information in official databases, such as those used in the EU and Canada and the UN Globally Harmonized System (GHS) of classification and labeling for classifying chemicals in its inventory.

A timeline for implementing Brazil’s plans has not yet been disclosed.

For additional information, please see:
http://www.mma.gov.br/seguranca-quimica/gestao-das-substancias-quimicas/gt-regulacao-de-substancias-quimicas-conasq

Throughout 2019 SILLAC thanks HAZCOM Warriors

Get to know the Hazcom Warrior Program

The Wounded Warrior Project contributes to chemical management compliance.

 

Who are HAZCOM Warriors?

The HAZCOM Warriors Program is comprised of injured veterans and their caregivers. The Program includes men and women who, while healing from injuries received during deployments and missions, specifically healing from post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), or other physical injuries, have approached a way to continue their service through chemical management compliance and implementation. The program allows the HAZCOM Warriors to become experts on exposure risks with a thorough understanding of what employers can do to help ensure workplace safety.

In 2018 SILLAC launched its SDS Authoring, GHS Management, and other Chemical Management compliance services and appreciates the work that HAZCOM Warriors have contributed to this year’s efforts.  SILLAC HAZCOM Warrior consulting model is a perfect fit for many nonprofits and small businesses who might otherwise be faced with either non-compliance or product deletion.

If you would like to find out more about the HAZCOM Warrior Program please contact us at lcuevas@sillac.com

 

How Chemical Management Compliance Can Save You Time and Money

Don’t leave your company’s regulatory compliance in the hands of third parties who do not know the laws and legal framework of Latin America and the Caribbean.

SILLAC has firsthand Chemical Management expertise knowledge on the laws and regulations of Latin America and the Caribbean (LAC) because we are a full-service international law firm specializing, precisely, in Latin American and Caribbean. We are, as our trade name suggests, Specialists in International Law on Latin America and the Caribbean.  Moreover, our specialists are Environmental Law, Occupational Safety, and Chemical Management experts in their respective LAC jurisdictions.

Unlike other providers of chemical management regulation, Specialists at SILLAC can assist clients efficiently and effectively freeing them from the burden of dealing with the complexity of chemical management compliance of their products.

Generally, chemical management providers rely on non-lawyer analysts with little or no skills in local laws of LAC jurisdictions, who look for regulations on the internet to build a “compliance” package. The “supplier-customer” relationship ends there; unless they sell the customer other products such as data sheets and labelling, however, it is often without follow-up, unless the customer has a complaint.

At SILLAC, we follow-up with our customers to ensure that they will always have the support they deserve and SILLAC’s mission describes our commitment to them:

  • For our customers to know what to do to meet the regulatory framework of Latin America and the Caribbean
  • Communicate with our clients with the utmost sincerity explaining the expectations of the diligent observation of the local laws and regulations
  • Walk with our clients, prepare them and guide them throughout their business in Latin America and the Caribbean.

At SILLAC we take our commitment to our clients very seriously and that is why, our customers are confident and trust that they comply with the regulatory framework of their jurisdiction (s).  Once you become our chemical management client, SILLAC conducts follow up to ensure that the products and regulatory services we provide are exactly what your business and products require.

We hope this will never happen, but SILLAC can guarantee that if your company is ever involved in any liability arising from non-compliance, we will stand behind it all the way. Therefore, not only is it logical, but it makes good business sense, to work with an international regulatory company that can provide all your chemical management compliance needs, including safety data sheets and labelling, as we do, and legal assistance.

This is one of the reasons why SILLAC, a chemical management compliance provider, can also provide you with legal support on legal issues arising from any activity involving chemicals, raw materials, or any other finished product in Latin America and the Caribbean.

In addition, SILLAC experts in chemical management can advise you on importing, exporting, marketing, and selling your products in LAC.  Other topics linked with Chemical Management are:

Industrial Compliance products

  • Environmental, Health and Safety (EH&S)
  • Labor Liability Legislation
  • Industrial and Commercial Property
  • Taxation

Also, please see our list of products and services in the Chemical Management Section:

Chemical Management Compliance

  • Safety Data Sheet (SDS) Management Plan
  • SDS Authoring, Management, Distribution, Hazard Communication, and Chemicals Regulatory Consulting
  • Globally Harmonized System of Classification, Labeling and Packaging of Chemicals (GHS).
  • Safety Data Sheet
  • Labeling
  • Packaging
  • Country-specific regulations: Classification, Labeling and Packaging (CLP)
  • New Chemical Product Registration Dossier
  • Chemical Import Registration and Authorizations