If you are exporting hazardous mixtures (for health and physical effects) into the EU and you don’t have an EU legal entity, then your customer, distributor or end user will be obliged to notify EU Member State poison centres.
The European poison centre requirements (under Annex VIII of CLP) put the obligation of notification of hazardous mixtures (for health and physical effects) onto the organisation placing products on the market within any given EU Member State. For non-EU organisations that do not have an EU-based legal entity – including those based in England, Wales and Scotland after the Brexit transition period ends – the obligation to notify will become the responsibility of the importer (the customer, distributor or end user of the product).
However, importers might find it difficult to complete the notification if they do not hold the full product information and if manufacturers are not prepared to share information about a product’s composition because of its commercial sensitivity.
How can I protect my composition data, but support my customer?
To protect confidential information, but still enable your customer to comply, you can make a voluntary notification using an EU-based legal entity and then share the Unique Formula Identifier (UFI) with your customer for them to make a UFI-based notification. This legal entity can be:
- Your own EU based legal entity.
- A customer’s legal entity.
- A third-party organisation such as NCEC.
NCEC is part of Ricardo, a multinational company, and has legal entities already in place across Europe (and the world). It is ready to act as an EU legal entity to enable you to make these voluntary notifications.
Can NCEC be my EU-27 -based Only Representative (OR) for the classification, labelling and packaging of substances and mixtures (CLP) Regulation?
Unfortunately, the role of OR does not exist under the CLP Regulation. Therefore, NCEC cannot take on the full legal responsibility for the notifications. We are working with key stakeholders to try and influence this decision.
We don’t have an EU-based legal entity, what should we do next?
To continue placing your product on the EU market, you will need to do one of the following:
- Provide your customer (importer) with product formulation information so that they can complete the notification.
- Create your own manned legal entity within the EU.
- Complete a voluntary notification to the European Chemicals Agency (ECHA) covering your consumers’ markets, thus allowing your customer to complete a UFI based notification.
- Your suppliers could complete the notification as 100% mixture in mixture (MIM), but this is more onerous for your customers.
Completing a voluntary notification may be the most cost-effective method as you provide the information direct to the poison centres rather than liaising through each of your customers – and repeating the process as your customer base grows. A voluntary notification only needs doing once and then the UFI can be supplied to each customer alongside the safety data sheet (SDS). The UFI would then remain valid until your product formulation changed. In addition, updates may be easier to implement as they wouldn’t require the co-operation of each customer.
This not only protects confidential information about your mixture(s), but also ensures you are supporting customers with their legal obligations while reducing their administrative burden.
It is cost and time-effective for the same organisation that completed the voluntary notification to complete the subsequent UFI notifications. Therefore, NCEC experts are happy to discuss how they can support you and your customer to manage these requirements.
How is the using an EU-based legal entity to submit a voluntary notification under Annex VIII of CLP Regulation different to using an OR for EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation?
To comply with REACH, organisations based outside of the European Economic Area (EEA) can appoint an EU-based OR to assume the tasks and responsibilities of importers. This can simplify access to the EU market for their products, secure the supply and reduce the responsibilities for importers.
ORs have to be:
- A natural person or a legal entity established physically in the EU.
- Equipped with sufficient knowledge in the practical handling of the substances and information related to them.
- Appointed by a mutual agreement with a manufacturer, formulator or article producer established outside of the EU.
- Responsible for complying with the legal requirements for importers under REACH.
ORs can represent more than one non-EU supplier, but must keep the information related to each of them separate.
The non-EU organisation is required to inform the importer(s) within the same supply chain of an OR’s appointment. The importers are then regarded as downstream users under REACH.
You are not an OR if:
- Your non-EU supplier is a distributor.
- Your only role is to act as a third-party representative in the data-sharing process under REACH.
For poison centres, the obligation to make the notification lies with the importer. For many organisations based outside of the EU, this will mean that their customers will need to make the notification. This is a critical change for customers of organisations based in Great Britain who will now become importers and be responsible for these notifications.
If you need any assistance for your poison centre notifications please contact us through the form on the side, email us at [email protected] or call us at +44 (0)1235 753654.