USA Regulatory News

Chile drafts a new regulation to further promote safe products among the ones used by children. These products will have to comply with the provisions established by the regulation and prese...

Chile drafts a new regulation to further promote safe products among the ones used by children. These products will have to comply with the provisions established by the regulation and present the certificate attesting conformity in order to be marketable.

The Regulation on Safety of Products for Children's Use is headed by the Ministry of Health and requires children’s products to consider flammability, physical, mechanical, chemical, and electromagnetic risks. 

In addition, the resolution proposes new maximum permitted amounts for phthalates and set new migration limits for the following solvents and monomers. They are as follows: 

* If possible that children put it in their mouths. 

The adhesives and glues for school, used in teaching activities in pre-basic, basic and secondary schools, may not contain in their composition pure organic solvents or mixtures in concentrations exceeding the following limits: 

The new rules are aimed at enhancing safety and good risk management of products used by children in Chile, as proposed by the Ministry of Health.

Last Update: 2021-11-30

In recent months, Chile has announced three main resolutions aimed at defining the goals, obligations, annual report’s content, and the framing of products that would fall within the packin...

In recent months, Chile has announced three main resolutions aimed at defining the goals, obligations, annual report’s content, and the framing of products that would fall within the packing management. Chile is truly embracing the Extended Producer Responsibility (EPR) to shape national policy. The EPR was officially incorporated into the national administration in 2016 by Law 20.920. 

In March 2021, the Ministry of the Environment (MMA) published Decree 12, responsible for establishing the objectives and obligations associated with containers and packaging under EPR. It also determines that manufacturers must meet progressive collection and recovery targets. The categories are divided into households and non-households and present the yearly progressive ambition as follows: 

• Household packing                                                                                          

• Non-household packing 

Manufacturers placing more than 300 kg of packing material into the market are subject to additional obligations other than fulfilling the indicated goals, which stands out: 

• Enroll in the Register of Emission and Transfer of Contaminants (RETC), and submit data through the platform 
• Present the Management Plan and Manufacturers that integrate such system 
• Submit an Annual Report no later than May 31st of each year.

The Annual Report contents are regulated by Resolution 1.090 enacted in September 2021. 

Accordingly, MMA proposed on September 2021, a resolution guideline to assist the public in identifying and categorizing the packing material addressed by the new packaging policy. Resolution Proposal 1.026 presents criteria for determining products that constitute packing, including the side or auxiliary elements. . Resolution Proposal 1.026 is open for public comments until October 21, 2021. 

Producers and manufacturers have 30 months to comply and avoid future fines and penalties. Those interested in knowing more about the EPR law or complying with the requirements discussed above can contact us @compliance@gpcregulatory.com.

Last Update: 2021-11-30

Chemical associations came together and published an open letter on the need for greater involvement and harmonization of regulatory principles. Associations from Argentina, Brazil, Chile, C...

Chemical associations came together and published an open letter on the need for greater involvement and harmonization of regulatory principles. Associations from Argentina, Brazil, Chile, Colombia, Mexico, and Uruguay highlighted the importance of cooperation, considering their common ground in achieving the Sustainable Development Goals 2030, strengthening activities with OECD, and appeasing regulatory differences. 

“Strengthened regulatory cooperation is an opportunity for Latin American countries to promote interaction, public-private engagement, and exchange resources more efficiently, making it possible to raise transparency and public trust in regulatory decisions”, the letter states. 

The guiding principles are based on: 

• Open dialogue, public consultation, transparency, and trust 
• Implementation of hard-law and voluntary initiatives 
• Mutually compatible regulatory models and regional convergence 
• Regulatory assessments and progressive adoptions 

In addition, the associations reaffirmed their commitment to establish and carry on the Latin America Regulatory Cooperation Forum (LARCF) activities. The letter on the Regulatory Cooperation Principle is available in English and Spanish, so is the Commitment Letter (English and Spanish). 

Last Update: 2021-10-29

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,00...

In October 2021, US EPA removed the confidentiality status for 377 substances, making their chemical status available to the public. According to the TSCA inventory, these chemicals make up about 8,000 of the 42,000 chemicals listed there.

In April, EPA listed 390 substances that will be moved to the public section of the inventory. Industries were given a period to raise concerns about the declassification of these chemicals. Of the 390 substances, 13 were found on the public inventory, and some were reported for having invalid accession numbers. This warranted a few changes before US EPA published the 377 substances to lose confidentiality status.

This list includes substances reported by companies as non-confidential in a CDR submission and those flagged during the inventory reset proceed from 2017 to 2018. As released by EPA, it will also be included in the next TSCA inventory update this year.

Last Update: 2021-10-26

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals. Accordi...

To get ahead of problems that can impact those who make and use PFAs, the US EPA has issued a 26-pages roadmap to set an approach for research, restricting, and remediating these chemicals.

According to the EPA Administrator, Michael Regan, "This comprehensive, national PFAS strategy will deliver protections to people who are hurting, by advancing bold and concrete actions that address the full lifecycle of these chemicals." 

This new roadmap includes the following:

• Imposes new testing and reporting requirements, strengthening the TSCA review of new PFAs

• Tightens restrictions on existing ones.

• Adopts an enforceable drinking water limit for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)

• Applies hazardous substance designations for certain substances.

• For substances not yet on the market, EPA will apply a rigorous premanufacture notice review process for new PFAS to ensure these substances are safe before they enter the market.

All these changes are in addition to the earlier revised assumptions about proper usage of personal protective equipment (PPE) and the lack of approval for PFASs submitted through a low volume exemption (LVE). 

Furthermore, to review and tighten restrictions on existing PFAs, EPA plans to issue TSCA section 5(e) orders and impose rigorous safety requirements as a condition of allowing the use of PFAs. You can download a copy of the roadmap here.

Last Update: 2021-10-21

On the 22nd of July 2021, the US House of Representatives passed H.R. 2467, the PFAS Action Act of 2021. This is a comprehensive framework for regulating 9,252 per-and polyfluoroalkyl substan...

On the 22nd of July 2021, the US House of Representatives passed H.R. 2467, the PFAS Action Act of 2021. This is a comprehensive framework for regulating 9,252 per-and polyfluoroalkyl substances (PFAS). Unlike a similar bill (H.R. 535) which was never considered by the Republican-controlled Senate in the last Congress, this bill was passed by a vote of 241-183.

The bill sets requirements and incentives, in a bid to limit the use of PFAs in the environment. All PFAS are to be tested by EPA for toxicity to human health and the environment.

Furthermore, the bill provides the following:

• Designation of PFOA and PFOS as hazardous substances under CERCLA. They are also designated as hazardous air pollutants under the Clean Air Act.
• EPA must decide within five years if the other PFAS should be labelled hazardous substances.
• Unsafe burning of PFAs wastes will be prohibited and incentives are to be provided for helping community water systems that are contaminated by PFAS.

Significant New Use Rules (Snur) draft guidance was released on 10 December 2020 to help businesses understand and comply with a TSCA Snur. This is the guid...

Significant New Use Rules (Snur) draft guidance was released on 10 December 2020 to help businesses understand and comply with a TSCA Snur. This is the guidance that defines what qualifies as ‘surface coating’ under the rule and the entities subject to the rule’s requirements. So far, no substantive change has been made to the guidance. 

However, alongside the new reporting rule proposed by EPA, the Snur guidance issued earlier this year was revoked. This guidance was released in the final weeks of Trump’s administration. According to the agency, it has “inappropriately narrowed the scope and weakened the prohibitions included in the Snur.”  

Most importantly, the rule is still in effect as only the guidance was revoked. The Significant New Use Rules (SNURs) says: 

• Companies must get the EPA approval before they can recommence the use of more than a dozen long-chain perfluoroalkyl carboxylate (LCPFAC) substances and perfluorooctanoic acid (PFOA). 

This rule also applies to imported articles containing compounds in a surface coating; this includes automotive parts, carpet, furniture, and electronic components. EPA also noted, during its announcement, that three PFAS have been added to the Toxics Release Inventory (TRI) in the early month of June. Also, the release of these chemicals will be reported by 1 July 2022 for 2021 calendar year data. The addition of these PFAS is made towards implementing the vitasl PFAS requirement of the NDAA. The NDAA, in line with the TRI Reporting Year 2021 directly added these three PFAS to the TRI list because they are subject to a SNUR under TSCA.  

Sources: United States Environmental Protection Agency 

Date: July 5, 2021