Plan ahead: Harmonised reporting obligations for hazardous mixtures in Europe are coming

By Nicolás Fuentes, Feica

The deadline for reporting of hazardous mixtures supplied to consumers will be 1 January 2020. There are further phased deadlines for reporting mixtures intended for professional and industrial use, on 1 January 2021 and 2024 respectively (although existing notifications made under previous rules will remain valid until 1 January 2025 if they do not change).

As one can imagine, this is no small task. ECHA, the European Chemicals Agency, is setting up technical and scientific guidance tools for companies in the EU, with the support and feedback from industry representatives of the main affected sectors. When ECHA, industry and authorities from Member States got together for these discussions, it became clear that some of the previously foreseen solutions will need to be developed in more detail, and some others will need to be reassessed.

Let’s take a look at what we know so far, and what we can expect in the two years leading up to the first deadline.

Guidance document

This guidance is being drafted with the active involvement of authorities and industry via the working group. Here, FEICA, in common with other associations, has had the opportunity to lead the drafting and structure of the text to ensure it becomes a useful source of practical information in the future. The first draft is expected at the end of this year, but this will be a preliminary text: the formal consultation process will start in 2018.

PCS (Product Categorisation System)

Harmonised Product Categories will be mandatory in industry notifications. This will be a single selection based on main intended use, aimed at helping appointed bodies and poison centres to understand the reporting and statistical analysis of poisoning incidents. This system should also be available by the end of this year.

Unique Formula Identifier (UFI)

Much has been said about the UFI. This is a new notification requirement and is mandatory for inclusion on the product label. ECHA is developing a UFI generator tool and an algorithm to be made available for companies to generate their own UFIs (expected Q1 2018). Several industry sectors, among them FEICA, have already signalled their concerns with the workability of the current rules for assigning UFIs to mixtures; a practical solution is expected by all parties.

PCN Poison Centre notification format

ECHA is planning to publish another online tool, this time to allow companies to benefit from a structured electronic format defining the harmonised information requirements. Even though it was possible for companies to experiment with the first draft tool, this is now obsolete! A renewed version taking into account feedback from industry and poison centres alike will go live in early 2018.

Central notification portal

At this stage, a central notification portal for all submissions at EU level is still an idea. It is something ECHA plans to offer companies in Europe, however the proposal is still being figured out: a feasibility study was completed and its results are being assessed. This centralised notification portal aims to facilitate the exchange of information among Member States while increasing efficiency for industry. Naturally, security and confidentiality concerns have been raised, and are the subject of debate currently at national level. Moreover, it is still not clear, and this will depend greatly on the outcome of the conversation between the representatives of the Member States, whether poison centres and appointed bodies will be obliged to accept notifications through this portal, or if on the other hand companies will still be able to notify directly to each individual body.

Next steps for the industry

• First, understand that importers or downstream users that place mixtures in the EU market classified as hazardous for human health or physical hazard are subject to these new requirements.
• It would be advisable to start identifying mixtures that require notification, and the information required in such notifications: product identifier, UFI, contact details, hazard identification, information on mixture components, and even additional information such as type of packaging, product category and intended use.
• Moreover, due to the expected changes and online tools, it may be wise to start considering the resources necessary for IT changes or updates within the organisation. Time flies, plan ahead!