REGULATION & COMPLIANCE
Structurally descriptive generic names must be consistent with the EPA guidance released on 22 June 2018 . This guidance is a living document and may be revised periodically .
Although examples primarily include masking one structural element , submitters can mask more than one structural element provided that they can justify the need to . The proposed rule would require more robust substantiation for the need to mask more than one moiety .
How to assert CBI
In order to keep or assert your CBI , firstly , ensure that your contact information is current in the Chemical Data Exchange ( CDX ). If the EPA has concerns or questions , they will contact the authorised official via an email alerting them to check the CDX .
With the first ten-year sunset period on the first CBI claims coming in 2026 , updating this information is especially important . Note that , when ownership of a company or unit of a company changes , you must direct a notice of transfer of ownership to the EPA via
CDX . The EPA also plans to provide public notice of expiring CBI claims , making it critical to re-substantiate at the correct time .
Secondly , you must maintain CBI confidentiality consistently for all sections of the TSCA . For example , when a chemical identity has been claimed as CBI in a Pre-Manufacture Notice , confidentiality must also claimed in the CDR report – otherwise , it will be lost .
In sum , the proposed TSCA rule intends to narrow CBI claims and make asserting , substantiating and tracking them more rigorous . These changes may affect every company that submits confidential information to the EPA .
CEPA update
The Canadian Environmental Protection Act , 1999 ( CEPA 1999 ) is an important part of Canada ’ s federal environmental legislation , aimed at preventing pollution and protecting environment and human health . In April 2021 , the government introduced Bill C-28 in the House of Commons as the first update to CEPA 1999 . 1 That August , when general elections were called , the bill was tabled .
In February 2022 , when Bill C-28 was not re-introduced in the House of Commons , the Senate of Canada introduced Bill S-5 ( Strengthening Environmental Protection for a Healthier Canada Act ). This bill would modernise CEPA 1999 for the first time in 20 years and make related amendments to the Food & Drugs Act .
The Senate ’ s fundamental role is as a complementary legislative body to the elected House of Commons . It acts as a reviewing chamber on proposed bills before they are passed . It also has a fundamental role in the representation of regional interests , and has become an important institution for the representation of minorities and groups ( including indigenous peoples , minority language and ethnic groups , and women ) underrepresented in the elected chamber .
Bill S-5 recognises that , under CEPA 2009 , every individual has a right to a healthy environment and the government has a duty to protect that right by strengthening the foundations for managing chemicals and other substances in Canada . Modernising it will ensure that the future of risk-based chemicals management in Canada can be continued as the original Chemicals Management Plan ( CMP ), which is seen as the gold standard worldwide .
Canada has completed more risk assessments and introduced more risk-management instruments than any other jurisdiction . Since the launch of the CMP , the government has categorised 23,000 substances , and of the 4,300 chemistries identified , it has assessed almost 4,000 chemistries as having potential exposures of concern . The balance of risk and precaution is a keystone of CEPA 1999 . ●
Reference : 1 : https :// www . canada . ca / en / services / environment / pollutionwaste-management / strengthening-canadian-environmentalprotection-act-1999 / bill-c-28-strengthening-environmentalprotection-healthier-canada-act-summary-amendments . html
Dr Rose Passarella
ASSOCIATE DIRECTOR - CHEMICALS GROUP
INTERTEK ASSURIS ( US ) k + 1 431 800 6984 J rose . passarella @ intertek . com j www . intertek . com
Dan Bastien
ASSOCIATE DIRECTOR - CHEMICALS GROUP
INTERTEK ASSURIS ( CANADA ) k + 1 905 542 1827 J dan . bastien @ intertek . com j www . intertek . com
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