Following developments in other countries around the world including Korea and Taiwan, the Brazilian Ministry of the Environment has proposed legislation to establish an industrial chemical registry as a prelude to risk assessment and management of priority chemicals. A draft of the legislation has been published here and comments are being accepted through 11:00 p.m. (Brasilia - Federal District, Brazil time; midnight U.S. EDT ) on August 14, 2016. An online form for submitting comments, presumably in Portuguese, is available here.
The draft legislation is available only in Portuguese but online language translation tools provide a good sense as to the scope of the legislation. The proposal shares much in common with the Malaysian Environmentally Hazardous Substances Notification and Registration (EHSNR) scheme although it is not limited to hazardous substances.
The proposal would require manufacturers and importers of non-exempt chemicals in quantities of 1 ton or more (there is a provision to require reporting at lower thresholds in special cases) to submit certain basic information to a National Registry of Industrial Chemical Substances (Registry) including the chemical name and CAS number, the annual tonnage band, uses, and GHS hazard classification. There is some provision for protection of confidential business information. Certain categories of chemicals are exempt such as R&D substances, impurities, human and veterinary drug and pesticide active ingredients, etc., but there are far fewer exemptions than available under EU REACH or other chemical laws. There is an interesting exemption for metals and their alloys in the form of plates, sheets, strips, billets, ingots, beams and similar forms for structural purposes.
At the moment no pre-market or pre-manufacture approval scheme is proposed. Instead, presumably new substances first imported in 1 ton or more per year by a manufacturer or importer would be subject to future reporting and then inclusion in the Registry.
It is contemplated that substances on the Registry will be prioritized on the basis of hazard and other factors for risk assessment and risk management. Companies that reported chemicals to the Registry would be required to submit information to support the risk assessment.
The draft legislation is only six pages in length and assumes the details will be fleshed out in regulations.
In terms of commenting by the August 14th deadline, aside from urging Brazil to develop a more comprehensive proposal that explains how the risk assessments will be conducted, the kinds of information that will be demanded from industry, the safety standard that will be used, and the procedures for making risk management decisions, it seems that at a minimum the draft legislation needs to:
- Make provision for non-Brazilian manufactures to provide information directly to the Registry through the use of an Only Representative or other third-party reporting mechanism;
- Expand the scope of exemptions to be more consistent with other chemical legislation; and
- Explain whether the program will be fully funded by the Brazilian Government or whether Industry will be required to pay.