By Sphera’s Editorial Team | March 10, 2017

Who? U.S. – Federal, U.S. Environmental Protectional Agency

 Alert #1:

Under the Toxic Substances Control Act, or TSCA, newly amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016, the U.S. Environmental Protection Agency announced that one goal was to “reset” the TSCA Inventory to denote active and inactive chemicals. In mid-January 2017, the EPA published a proposed rule soliciting comments (82 FR 4255), with the comment period ending March 14, 2017.

On February 27, 2017, the EPA published the updated TSCA Inventory on its website. This most-recent version includes a new flag designating which chemical substances were active in commerce. This status was determined based on reporting from the 2012 Chemical Data Reporting cycle. The EPA expects to add further “active” commercial activity designations for reported chemical substances. The rule that requires EPS to make the active-inactive distinction is required to be finalized by the EPA by June 22, 2017.


Affected companies will have additional reporting obligations to help the EPA make the active/inactive designations. In the proposed rule, the EPA has suggested requiring a retrospective electronic notification of substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the 10-year period ending on June 21, 2016. The EPA would then use these notifications to distinguish active substances from inactive substances.

Who? Canada – Federal, Canadian Environmental Protection Agency

Alert #2: Proposed Addition of Natural Gas Condensates to Schedule 1 of the Canadian Enivronmental Protection Act

The government of Canada has proposed to add natural gas condensates, or NGCs, to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act of 1999, or CEPA. The government defines NGCs as a class of substances related to the petroleum sectors that share similar sources, properties and use. Although NGCs were thought to be present in consumer products, the government’s assessment only identified industrial uses for these substances in Canada.

NGCs were assessed to determine whether they could constitute a danger to the environment or human health in Canada and because the NGCs met one or more criteria, they were proposed to be added to Schedule 1. They will be added as #138 on the list.


Industry in Canada that generate NCGs need to be aware of the pending listing and compliance obligations.

Who? European Union, European Chemicals Agency

Alert #3: Flame Retardant decaBDE Added to REACH Annex XVII (Restrictions)

Regulation (EU) 2017/227, which was published on February 10, 2017, has added Bis(pentabromophenyl)ether (also known as decabromodiphenyl ether or decaBDE) to Annex XVII of the REACH Regulation (1907/2006) as entry #68 (CAS No 1163-19-5; EC No 214-604-9).


Manufacturers need to be aware of the new restriction for decaBDE, which will be subject to a limit of 0.1 percent (by weight) for use in the production of or placing on the market in another substance as a constituent, a mixture or an article after March 2, 2019.

Who? European Union, European Chemicals Agency

Alert #4: ECHA Draft Recommends Seven Substances for Authorization

On 2 March 2017, the ECHA announced it had assessed seven substances of very high concern, orSVHC, on The Candidate List as recommended to be prioritized for inclusion on the Authorization List (Annex XIV). The substances are as follows:

Name EC Number CAS Number
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof] (karanal group)
1-Methyl-2-pyrrolidone (NMP) 212-828-1 872-50-4
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328) 247-384-8 25973-55-1
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) 223-383-8 3864-99-1
2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350) 253-037-1 36437-37-3
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320) 223-346-6 3846-71-7
1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5) 271-094-0 68515-51-5
272-013-1 68648-93-1


The ECHA is accepting comments until June 2, 2017. In addition, the ECHA advises downstream users of substances to communicate relevant information regarding their uses and conditions of use up the supply chain.

Who? European Union, European Commission

Alert #5: Member States Unable to Agree on Criteria to Identify Endocrine Disrupting Chemicals

The Member States have not agreed to the criteria proposed by the European Commission for the identification of endocrine-disrupting chemicals, or EDCs, in spite of changes made by the commission in response to earlier criticism. While some Member States were willing to approve the proposed criteria, others were concerned about a proposed revision to permit EDCs in biocides and pesticides if the risk they posed to humans and other organisms was negligible.

The two main issues remaining are 1) whether chemicals that are suspected of having endocrine-disrupting properties should be included in the definition and 2) how to apply the EDC criteria to biocides and pesticides.


Meetings on this topic have been ongoing since June 2016 and there is no agreement yet. Businesses that may be affected by the final decision will need to continue to await the final outcome.