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Join ChemADVISOR's Ancuta Rusu as she describes the global polymer registration requirements and explains how ChemADVISOR can help you navigate them.  The presentation will focus on requirements in North America, Europe and Asia.

 

Don Montgomery with Abigail Rose

ChemADVISOR retiree Don Montgomery meets his grandchild, Abigail Rose, born on July 16.  Mother and daughter are doing great!

by Safia Korati

In their newsletter of June 2015, ECHA announced that it has screened and selected approximately 200 substances from the REACH registrations for further scrutiny by the Member State competent authorities.

In the context of the Roadmap 2020, ECHA, the Member States and the European Commission have developed a common screening approach to identify substances with certain hazards, exposures and risk profiles. Screening potential substances of concern is vital if all relevant substances of very high concern (SVHCs) are to be on the Candidate List for SVHCs by 2020.

Steps in this process:

  1. IT screening by ECHA

The selection is based on an automated screening focusing on substances with potential CMR (carcinogenic, mutagenic or toxic to reproduction), PBT (persistent, bioaccumulative, toxic), endocrine disrupting or sensitising properties. The screening is based on information available on ECHA's registration database and in the C&L Inventory as well as external sources, such as assessments made by other regulatory authorities. Screening scenarios have been developed which can be used in IT based mass screening exercises. This is the first phase of screening and is conducted once a year.

  1. The Manual Screening by Member States

The substances identified through the IT screening are then manually scrutinised by the Member States. The manual screening better defines the hazard profile or the risk based concerns for each substance. It aims to confirm if further steps need to be taken.

  1. Potential outcomes

After the manual screening, substances of potential concern will be processed depending on the need for further additional information or for further regulatory action:

  • Compliance Check: If the registration doesn’t comply with the registration information requirements, ECHA will request that the registrant submit further information or carry out additional testing.
  • Substance Evaluation: Member States carry out substance evaluation, which aims to clarify whether the use of a substance poses a risk to human health or the environment. As a result, registrants may be asked to send additional information or perform tests that are not part of the standard requirements for REACH registration.
  • RMOA: Where a concern is identified, the Member State, or ECHA at the request of the Commission, can choose to perform a risk management option analysis (RMOA) to identify the best way forward. The outcome can be:
    • a proposal for harmonised classification and labelling;
    • SVHC identification and inclusion on the Candidate List of SVHCs. This may eventually lead to inclusion on the Authorisation List;
    • a proposal for restriction;
    • a decision that the substance needs to be discussed under other legislation; or
    • no further action.

What to do as a registrant?

The main source of information for screening is the registration database. Therefore, it is important that your registration dossiers are up-to-date and that the information on uses, tonnages and conditions of use are accurate. This information is used to prioritise substances for further work but also to find out if a substance is of lower priority.

You can see which substances are being examined on ECHA's website. The PACT (Public Activities Coordination Tools) helps you to follow-up the status of your substance. Check it regularly and update your dossier if needed.

References:

Additional information on the common screening approach for REACH and CLP can be found at: http://echa.europa.eu/documents/10162/19126370/common_screening_approach_en.pdf

Additional information on the SVHC Roadmap to 2020 Implementation Plan can be found at: http://echa.europa.eu/documents/10162/19126370/svhc_roadmap_implementation_plan_en.pdf

Additional information on the Public Activities Coordination Tool (PACT) can be found at: http://www.echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern/pact

by John J. Kowalski, CHMM

On July 20, 2015, the U.S. Environmental Protection Agency (EPA, the Agency) published a direct final rule to amend the Toxic Substances Control Act (TSCA) Section 5 electronic reporting regulations. This direct final rule is effective January 19, 2016, without further notice, unless the Agency receives adverse comment on or before August 19, 2015. If EPA receives adverse comments on this action, the Agency will withdraw the rule, before its effective date, and issue a proposed rule with a 30-day period for public comment.

This direct final rule amends the TSCA Section 5 Premanufacture Notification (PMN) and Significant New Use Rules (SNURs) at 40 CFR Parts 720, 721, 723 and 725 by mandating the use of an updated version of the e-PMN reporting software. Whereas the current version of the e-PMN software, which EPA refers to as the “thick client version,” is a downloadable software system, the new version, which EPA refers to as the “thin client version,” will operate as a ‘‘cloud’’ software system. In addition, the direct final rule:

  • extends electronic reporting requirements to notices of bona fide intent to manufacture;
  • corrects certain regulatory cross-references in 40 CFR Parts 720 and 721;
  • standardizes the use of the term “manufacture” and similar language in 40 CFR Parts 720, 721, and 725; and
  • specifies electronic reporting procedures for the notification of new manufacturing sites for chemical substances for which exemptions were granted by EPA under 40 CFR 723.50.

Under the direct final rule, TSCA Section 5 submissions will be prepared and submitted through EPA’s Chemical Information Submission System (CISS). CISS is a web-based reporting tool developed by EPA for use in electronically submitting data, reports and other information under certain sections of TSCA to the Agency. The thin client version of the e-PMN software is a new submission module within CISS. Other submission modules in CISS are already used for Chemical Data Reporting under TSCA Section 8(a), test data submissions under TSCA Section 4, preliminary assessment information reporting under TSCA Section 8(a), health and safety data reporting under TSCA Section 8(d) and substantial risk reporting under TSCA Section 8(e).

Unless EPA receives adverse comment on the direct final rule on or before August 19, 2015, it will accept submissions using the thin client version of the e-PMN software beginning on September 3, 2015. After January 19, 2016, use of the thin client version of the e-PMN software will be mandatory.

Reference:

Environmental Protection Agency. “TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting” Federal Register 80 (20 July 2015): 42739-42747. http://www.gpo.gov/fdsys/pkg/FR-2015-07-20/pdf/2015-17737.pdf