The Acta Group (Acta®) has been closely tracking the development of Brazil’s Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação), which still only exists in draft form. As discussed in our Global Regulatory Update for June 2017, “on May 22, 2017, it was announced that, due to changes inside the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MMA), the extraordinary meetings of the National Commission of Chemical Safety (CONASQ) were rescheduled for the end of June. As part of the development of the Regulação, all of the comments received during the public consultation period were to be discussed at a meeting of CONASQ.” This meeting has now taken place, and the 801 comments from 236 individuals have been reviewed. Almost two thirds (~61 percent) were received from the Private Sector, followed by Civil Society (25 percent), Government (six percent), Academia (five percent), and International (three percent). These comments will be taken into account when revising the draft regulation prior to its submission to the full Congress, as will be discussed later.
When the Regulação was first published as a draft on June 30, 2016, in the Brazilian Official Journal, the Diário Oficial, a 45 day notice and comment period was established. This period needed to be extended, however, due to the volume of comments which were received by the MMA. Similarly to the United States, Brazilian authorities must review all comments submitted during the period.
Comments received by CONASQ and the MMA varied greatly, from those who felt the Regulação was unduly broad in its scope and should be refined to be less burdensome to industry, to those who believed that the final version of the Regulação should be an all-encompassing legislation, regulating such relatively-disparate categories as pharmaceuticals, veterinary products, radioactive substances, research and development (R&D) substances, residues, reaction intermediates, and nanomaterials.
Some of the major themes of comments received by CONASQ and the MMA were as follows:
- Respondents generally preferred to remove the term “Industrial” from the scope of the Regulação (thus making it more expansive). Presently, in Article 1, the Regulação defines the scope of chemicals subject to the regulation as “o cadastro, a avaliação e o controle de substâncias químicas industriais, com o fim de minimizar os impactos adversos à saúde e ao meio ambiente (The registration, evaluation and control of substances industrial chemical [sic], in order to minimize adverse impacts on health and the environment).”
- Respondents preferred the addition of several terms to the Definitions section, such as “food additive,” “article,” “monomer,” “polymer,” and “UVCB (substance)” (a chemical substance of Unknown or Variable composition, Complex reaction products and Biological materials). Presently, none of these terms are included it Article 2 of the draft Regulação. Article 2 only provides definitions for the substances subject to the regulation: additive, impurity, intentional mixture (same as "mixture" under the Toxic Substances Control Act (TSCA), at 40 C.F.R. § 710.4(c)(2)), and finished product (defined as the final product intended for the consumer, which does not require modifications or “preparations" to be marketed).
- Respondents advocated for a designated “legal representative” (such as an in-country agent) to provide the information required by the Regulação. As presently written, Article 5 sets out the notification and other reporting requirements for producers and importers of industrial chemicals, but it is silent as to who is able to make such notifications to the MMA.
- Similar to the second bullet point (above), respondents supported an expansion of the scope of the Regulação to include such categories as pharmaceuticals, veterinary products, radioactive substances, R&D substances, residues, reaction intermediates, and nanomaterials; many of these categories are exempt from chemical substance notification schemes in various industrialized countries, as they are often regulated under other, more specific statues. Including such categories, and their attendant substances, in the scope of the Regulação would challenge conventional “wisdom” concerning industrial chemicals management, and would likely also serve to make the Regulação unwieldly.
- Importers preferred to have the obligation to register substances and to report their attendant volumes fall solely on the producer(s).
- Respondents generally supported a requirement for mixtures, as well as substances, to have a registration obligation. As currently written in Article 5, the Regulação would only require notification for substances, which are defined as those with a Chemical Abstracts Service (CAS) Registry name and number, and with a discrete chemical formula.
- At present, the period for updating volumes of notified substances to the MMA is not specified in the Regulação. Article 6 states that the data required to be reported per Article 5 (identity of the producing company or importer, identity of the substance, including its CAS registry name and number, as well as its structural formula, the quantity produced or imported during the year, the use(s) of the substance, and the hazard classes -- specifically health and environmental -- according to the Globally Harmonized System of Classification and Labeling (GHS)) must be updated whenever there is a change in use, quantity produced or imported per year, or when the GHS health and/or environmental classification changes. Many of the respondents advocated codifying this reporting period as annual.
- Respondents requested that use information (Article 5) should only be required for substances that meet the category definitions under Article 2. It is believed that these respondents are implicitly requesting two different aspects; first, the development of a “positive list” of substances subject to the Regulação, as opposed to requiring notification of all substances in Brazil which meet these categories, and secondly a degree of protection for Confidential Business Information (CBI), which will be discussed later.
- Respondents commented that they would prefer only a “qualified person,” defined in the comments as a chemist or equivalent person, to be able to submit information required under Article 5. While perhaps a somewhat “esoteric” request, the request likely stemmed from commenters wishing to ensure the technical accuracy of data submitted.
- As written, Article 5 of the Regulação sets the threshold reporting requirement at equal to or greater than one ton per year. Respondents requested that this lowest tier reporting volume be reduced to 100 kg/year.
- A substantial number of respondents commented that they would like the Regulação to clearly define what is considered CBI, and to develop strong mechanisms for managing and protecting CBI. As written, the Regulação is vague as to how CBI will be managed. Article 6 raises the term, but -- perhaps because the current version is only a draft -- does not contain any specifics on the topic. Subsequent conversations with a member of the MMA, however, have revealed that the final version of the Regulação will include provisions for the submission, management, and protection of CBI.
- In what is perhaps a nod to ECHA/NA/16/36, the European Union’s (EU) new requirement for skin sensitization testing under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, which entered into force on October 11, 2016, and which makes non-animal testing the default requirement, many of the respondents requested the MMA to implement a ban on animal testing (as it relates to any data which may need to be submitted). The current version of the Regulação does not require any toxicology test data to be provided, however.
- Article 9 of the Regulação lays out the criteria by which industrial chemicals may be “flagged” for further review by the Industrial Chemicals Technical Committee, and Article 10 establishes the Deliberative Committee of Industrial Chemicals (composed of representatives of the Environment, Health, Labor, and Industry Ministries), who will determine any risk management procedures to be adopted, relative to the chemicals subject to the regulation. Respondents requested that an Appeals Board to review the decisions of the Technical and Deliberative Committees be established, to provide an avenue for challenging their decisions.
The subsequent steps in the process include CONASQ publishing a detailed review of all 801 comments received, as well as their decision for accepting or rejecting them, and then approving the final text of the draft Regulação. Next, the competent authorities -- the Ministries of Environment, Health, Labor and Industry -- will review the final draft, incorporate any changes they see fit, and grant their approval. Finally, the final draft will be sent to Congress -- estimated presently to be done in early 2018 -- for consideration and promulgation.
More information on the draft Regulação is available on Acta’s website, including several memoranda and materials from two well-attended webinars:
- A Critical Review of Brazil's Just-Published Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais);
- Current Opportunities and Challenges with Chemical Substance Regulation in Mexico and Central and South America (webinar); and