ECHA

The first compliance date for harmonised reporting of hazardous mixtures intended for consumer use has been postponed until 1 January 2021. Industry has welcomed the additional time to prepare their poison centres notifications to appointed bodies. Three companies give advice to those preparing for the first compliance date.

Chugoku Paints B.V., MANE, and Arkema (with their affiliate Bostik) are three companies working in different fields of business, but all deal with hazardous mixtures that will need to be notified to poison centres. Their preparations to meet the new obligations are already well underway.

Working through uncertainty

The latest amendment to Annex VIII to CLP, containing among other things the postponement of the first compliance date, will not be the last set of changes – more are expected in 2020 to address some workability issues. For example, discussions are still ongoing related to the open questions on how to make notifications when dealing with multiple suppliers for mixture components.

Marc Willemse. Image: Marc Willemse.

But regardless of the changes, the preparatory work for the notifications must be kicked off now, if it has not been started already. Notifications should, however, only be submitted to Member States that have indicated their readiness to accept submissions through the ECHA Submission portal.

The harmonised information requirements for the poison centre notifications are different from the national requirements currently in place. “We advise affected companies to make an inventory of which data is required, what they already have available and what they need to collect from other sources. For example, pay particular attention to required concentration ranges as mentioned in the regulation,” Marc Willemse, Manager Regulatory Affairs at Chugoku Paints B.V. explains.

Depending on the size of your company and your product portfolio, preparing and submitting notifications may mean a high workload. “Our tip would be to start by carefully analysing your portfolio, including all your mixtures sold to EU customers. We are also members of several international and national working groups, which helps us to stay up-to-date and get the latest information. We recommend others to do this, too,” says Romano Massara, VP Global Regulatory Affairs & Product Safety Fragrances at MANE.

Patricia de Camaret, Head of Products Regulatory Services in the Product Stewardship and Regulatory Affairs Directorate of Arkema France, who also represents the views of their affiliate, Bostik, points out that the ongoing discussions related to the final legal text could also be seen as an opportunity for industry to help the legislation find its final form. “Companies can be active in the current discussions with ECHA, the European Commission, trade associations and sector groups on the topics that are still under review. Our expertise is essential in finding the right solutions for implementing the legislation so that current issues, such as the mixtures in mixtures management, particularly related to multi-suppliers management, can be solved in a sustainable way.”

Importance of supply chain communications

Romano Massara. Image: Romano Massara.

The different compliance date for mixtures intended for consumer or professional use, compared to the one for industrial use, stresses the role of supply chain communications.

“For us, it is important to heavily invest in customer communication so that we get to know as much as possible about the final use of our mixtures and the countries where the products are put on the market. We need to keep in mind when putting together this information that downstream users cannot use our Unique Formula Identifier (UFI) in their own notifications unless we have indicated upstream in which countries the products are placed on the market,” Mr Massara emphasises.

Regardless of where the company is located in the supply chain, it is the end use of the mixture that defines the compliance date. “Suppliers who are upstream of the supply chain must realise that downstream users, especially those who are close to consumer uses, need information as quickly as possible to be able to do their own notifications in due time,” Ms de Camaret says.

As the number of distributors involved in the supply chain increases, the more complicated the work gets and so, more advance planning is required. “Our affiliate Bostik has numerous distributors. We have already started to send letters to them, explaining their role and responsibilities under Annex VIII to CLP. Now we wait for their answers so that we can continue building efficient solutions together,” Ms de Camaret adds.

Mr Willemse highlights the concern that any delay in the work of one actor in the supply chain may have consequences on how other companies can prepare. “We rely on information provided to us by our raw material suppliers. We have already requested some of them to provide UFIs regarding certain mixtures in mixtures but they have decided to wait with their submissions.”

Deciding what tools to use

The ECHA Submission portal is an online tool that companies can use to directly prepare and submit their poison centre notifications. However, industry is not obliged to use this portal.

“We had the opportunity to test the portal and as we expected not to have our own IT system in place at the time when ECHA’s system-to-system service is published, we decided to start using the ECHA Submission portal,” Mr Willemse explains.

For companies with a big product portfolio, it might make more sense to use their own IT systems for creating notifications using system-to-system service.

“We chose to integrate the preparation of notifications and the generation of UFIs in our own IT systems, which will be able to build the full notification with the technical completeness checks in place and feed the ECHA Submission portal using the system-to-system service. Nevertheless, we think that it is also necessary to know the ECHA Submission portal well to be able to submit the notifications manually, if needed,” Ms de Camaret says.

Expectations for harmonisation

As the notifications are currently made separately for each Member State where the mixture is placed on the market, the harmonisation will cut repetitive work and the need to get familiar with different requirements for the submitted information. “For us, it is easier to use one unified portal instead of different kinds of national systems. However, in some Member States additional national obligations may still apply,” Mr Willemse explains.

Ms de Camaret looks forward to harmonisation and the new EU portal, which allows companies to notify several Member States through one submission. But despite the strict security requirements that are in place to manage authorities’ access to confidential information, she raises some concerns related to the new IT solutions and databases. “We are still worried about the security of the database regarding the possible risks related to leaks or misuse of the confidential information. We must be able to fully trust the effectiveness of the firewalls in place.”

The final legal text is still being discussed, and companies may have many questions during their preparations. But in the long term, the benefits are expected to outnumber the challenges. “Harmonisation is always welcome. We believe that organising the work around the notification process will become much easier in the long run,” Mr Massara concludes.

5 tips to prepare for the first poison centre compliance date

1. Kick off your preparations and check which Member States accept submissions in the new format through the ECHA Submission portal
2. Analyse your portfolio and make an inventory of what data you have at hand and what you need to collect
3. Take an active role in working groups, trade organisations and sector groups – stay up-to-date and share your expertise
4. Invest in supply chain communications – your supply chain needs your information
5. Decide which tools to use – prepare your notifications online using the ECHA Submission portal or use your own IT-tools through the system-to-system service

The companies   Chugoku Paints B.V. is a daughter company of Chugoku Marine Paints Ltd. Japan. It produces paints and coatings for ocean-going vessels and yachts, as well as industrial and offshore constructions. The group has around 2 300 employees.   MANE is a flavours and fragrances company with more than 6 000 employees globally serving food and drink industry as well as hair, skin, fabric and home care products.   The Arkema Group, with 20 000 employees, produces specialty chemicals mainly for professional purposes. Its affiliate Bostik works on adhesives solutions for industrial, construction and consumer markets.

Did you know?   At the end of October 2019, the European Commission adopted the amendment to Annex VIII to CLP including the proposal to postpone the first compliance date for harmonised poison centre notifications to appointed bodies. This adoption is followed by a two-month period of scrutiny by the European Parliament and Council. If neither of them objects, the adoption enters into force. The date to notify mixtures intended for consumer use will be postponed from 1 January 2020 to 1 January 2021. Other compliance dates for professional use and industrial use only will not be affected. The Commission is also working on solving some of the concerns raised by stakeholders on the workability of the notification requirements. Solutions for these will be published in another amendment to Annex VIII in 2020.

Further information:

Poison centres

Overview of Member states decisions on implementing Annex VIII to the CLP [PDF]

ECHA Submission portal updated to include system-to-system service, News release 30 October 2019

Commission adopts change to first compliance date for reporting to poison centres, News release 6 November 2019

Interview by Päivi Jokiniemi

Published on: 14 November 2019

Top image: © Pixabay/PIROD4

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