Double exposure of scientist hand holding laboratory test tube

By Jenny Butcher, Chemicals Executive, REACHReady

Setting the Scene

Back in 2016 Member States voted in favour on the Commission’s proposal to harmonise information submitted to poison centres on hazardous mixtures. Following this vote Annex VIII to CLP was published in 2017 highlighting the harmonised information relating to emergency health response. But what does this mean for industry? Article 45 of CLP requires Member States to appoint a body for receiving information on the composition of hazardous mixtures that are placed on the market. However, the requirements for each Member State differ meaning that companies have to submit different data in different formats across the EU. The introduction of Annex VIII implements a harmonised format to the notification submitted to the Member States.

When do I have to notify?

The amendment to CLP doesn’t apply until 1 January 2020 BUT notification is already a legal requirement in most Member States. Therefore, if you notify before the amendment comes into force you have until 1 January 2025 to update to the new format. However, if you haven’t notified the following deadlines, determined by the mixture’s final use, will apply; consumer use 1 January 2020, professional use 1 January 2021, industrial use 1 January 2024.

What information do I need to submit?

Part B of Annex VIII details the information that is required for the submission. The notification should include the following data; product identifier with trade names and Unique Formula Identifier (UFI), details of submitter consistent with the label details, classification of the mixture and label elements, mixture composition within set concentration bands, toxicological information & type and size of packaging along with the product categorisation code.

How do I submit a notification?

ECHA developed several tools at the beginning of 2018 that will aid companies when making a notification. These include the Poison Centres Notification (PCN) format, UFI generator and EU Product Categorisation System (EU PCS). The PCN format is the structure in which information on hazardous mixtures has to be submitted to the Member State appointed bodies. The format is based on the data requirements stated in Part B of Annex VIII and will be compatible with IUCLID 6 from October 2018 after its scheduled update.

The UFI is a new notification requirement under Annex VIII and will need to be included on the product label. The UFI links the notified mixture information to a specific product on the market. The UFI generator uses the company’s VAT number and mixture formulation number to create a 16 digit alphanumeric code. The final version of the UFI generator is already available via the poison centre website.

The EU PCS was designed to help companies describe the intended use of their mixture. Each mixture will need to be assigned a single product category. Where mixtures have dual or multiple uses only the main intended use would be selected. The product category needs to be included in the notification.

Throughout 2018 ECHA will be developing a centralised submission and dispatch system – PCN portal. It is expected that the first version will be launched in Q1 2019 with further updates later that year.

Foreseen issues?

Several industry sectors have raised workability issues with the requirements of Article 45 and Annex VIII. A major concern for many sectors is the narrow concentration ranges that have to be applied to the mixture composition which could lead to thousands of individual notifications. To look into these issues the European Commission has initiated a new study which is expected to last for one year with interim results due beginning 2019.

REACHReady’s Recommendations

  • Notify today under the current regulation in order to benefit from the longer transitional period until 1 January 2025
  • Start making preparations by assessing product portfolios to determine the final intended use and therefore the deadline for notification under the harmonised format
  • Start producing UFIs and set up a management system to track the product – UFI combinations