There are several regulatory updates for hazardous mixtures that product stewardship professionals should be actively working to address if they sell products in either the EU or Chinese markets and haven’t already determined how to remain compliant. With ESG performance becoming a greater focus for companies, managing hazardous mixture data effectively is imperative.
Sphera presented a session on a few global regulations that impact hazardous mixtures at its virtual Product Stewardship Summit on June 28-29. The presentation included information concerning Poison Centre Notifications (PCNs), China QR codes and REACH Annex II.
EU Poison Centre Notifications
Under the umbrella of the European Chemicals Agency (ECHA), the Classification, Labelling and Packaging (CLP) regulation provides a harmonized system for classifying hazardous materials across signatory regions and countries. Annex VIII of the CLP regulation requires that importers and downstream users that sell hazardous mixtures on the EU and EEA markets submit a specific set of information to poison centers in their territories.
Data required for submission includes market placement, product category, packaging, unique formula identifier (UFI) codes as well as the composition, physical/chemical properties and hazards of products. Data must be submitted in an .i6z file, which is provided by ECHA.
Requirements went into effect for hazardous mixtures with consumer or professional uses on Jan. 1, 2021, while mixtures exclusively used for industrial purposes will require notification beginning on Jan. 1, 2024. There is also a transitional provision that can apply for mixtures that were already notified according to existing national procedures that were in place prior to the publication of Annex VIII, as long as there are no updates needed to that notification prior to Jan. 1, 2025. The latest PCN format update occurred in late 2021, allowing companies to prepare and submit dossiers for groups for the first time. The next major PCN format update is planned for April 2023.
QR Codes for Labels in China
China’s hazardous chemical registration system was recently updated and a QR code automatically generated from the registration system is required on product labels. “One Chemical, One Company, One Code” is the official slogan that is used to summarize the requirements. However, since products can be grouped together for registration, in some specific cases there can be one QR code that applies to and should be used for multiple products. When a QR code is scanned, the information that is returned includes identification, hazards, first-aid, accidental release measures and extinguishing methods, basically providing what could be considered a digital label.
REACH Annex II
There are significant updates to Annex II of the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The major updates in this round of changes relate to information required on the safety data sheet (SDS) for nanoforms, endocrine disruptors and information required in section 3 of the SDS. The updates are intended to increase transparency.
For nanoforms, sections 0.1.3 and 1.1 state that “the word ‘nanoform’ must be appended to the substance in each relevant section whether and which different nanoforms it covers and link the relevant safety information to each of those nanoforms.” When “nanoform” is used, the substance must be identified as such throughout the SDS.
According to sections 3.1 and 3.2, registered and nonregistered substances which cover nanoforms and particle characteristics must be included in Section 3 of the Substance and Mixture SDS. Section 9 states that if a substance is a nanoform or if the mixture contains nanoforms, those characteristics shall be indicated in this subsection or referred to if already specified elsewhere in the SDS.
Moving on to endocrine disruptors, REACH Annex II states that substances with endocrine-disrupting properties must be noted under “Other Hazards” on the SDS. These substances are defined as having endocrine-disrupting properties, which are included in the list established in accordance with Article 59(1).
Also included are substances identified as having endocrine-disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605. Both regulations incorporate the same criteria for endocrine-disrupting properties with respect to humans and non-target organisms.
For Section 3, mixtures meeting the criteria for classification which contain substances deemed endocrine disruptors should be disclosed at a concentration greater to or equal to 0.1%. This is also the case for mixtures not meeting the criteria for classification but contain substances deemed endocrine disruptors.
A new sub-heading called “11.2.1 Endocrine disrupting properties” has been added to Section 11.2. It adds brief summaries of the health effects caused by endocrine-disrupting properties. A new sub-heading called “12.6 Endocrine disrupting properties” has been added to Section 12, adding summaries on adverse effects on the environment caused by endocrine disrupting properties. REACH Annex II does not provide guidance on the type of information that should be communicated, but the ECHA guidance provides examples of brief summaries which help understand what needs to be provided in these sections.
By far the biggest, and most noticeable change to section 3 of the SDS is the requirement to include specific concentration limits, the M-factors and the acute toxicity estimates (ATEs) for substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or determined in accordance with Annex I to that Regulation. This includes self-derived ATEs or M-factors.
Updates to section 3 disclosure requirements for aspiration hazards, respiratory and skin sensitizers effectively bring REACH into alignment with CLP generic cut-off values and elicitation limits, including when there are specific concentration limits that apply. The changes to disclosure mean that enterprises may need to have additional components in section 3 of their SDSs in order to remain compliant.
Now more than ever, companies are using data to their advantage. Digital transformation will allow companies to continue to drive operational improvements in the long term. As the global shift toward mandating ESG reporting continues, leveraging hazardous chemical data effectively will become even more critical.