ECHA

The harmonised requirements for poison centre notifications following Annex VIII to the Classification, Labelling and Packaging Regulation will start to apply stepwise from 1 January 2021. As a response to certain concerns raised by companies, the European Commission has adopted an amendment to the legal text which includes practical solutions that will help companies meet their obligations.

This amendment, which is expected to enter into force in early November 2020, addresses concerns that industry has been raising since the new requirements were first introduced. The aim is to give companies a toolset to tackle those issues that could otherwise turn out to be a notification show stopper.

While the amendment aims to take some of the administrative burden off from companies, the solutions offered are prepared keeping in mind the information needs of poison centres. This means that poison centres will still receive sufficient information in the notifications to carry out their work efficiently and provide emergency health responses.

 

Point-of-sale paints – avoiding unnecessary notifications

Bespoke paints refer to those mixtures which are formulated in a limited amount at the point of sale to create a certain colour to satisfy customer demand. To meet the original requirements in Annex VIII, all these final mixtures would need to be notified to poison centres before they are placed on the market – that is, sold to the customer. In addition, each label would need its own unique formula identifier (UFI).

Since there are potentially countless colours that stores can formulate for their customers, having to notify each of them in advance and include the UFI on the label would create a huge administrative burden to retailers. On one hand, it would result in a high number of notifications for paints that, in many of the cases, would never even end up on the European market. On the other, if the retailer fulfilled their obligations, it would lead to unacceptable delays for customers who want to buy the paints.

Since poison centres have only reported a low number of incidents related to the use of bespoke paints compared to other household hazardous mixtures such as cleaning products, the Commission has included an exemption for these in the amended legal text. Formulators are freed from the notification obligation and the duty to create a UFI for each possible bespoke paint. However, suppliers must still create a UFI and notify each individual hazardous mixture – meaning the paint base, the tinter mixtures and toners – included in the bespoke paint and all the relevant UFIs have to be included on the label of the final product at the point of sale.

The exemption does not cover those paints that have been pre-ordered by industrial or professional users, or consumers.

 

High variation of composition in construction products – standard formulas available

Certain construction products, including ready-mixed concrete, gypsum and cement, may contain raw materials for which the composition varies from batch-to-batch or might even be unknown. This can lead to situations where it is very difficult to submit the required information to poison centres.

Industry representatives have proposed a set of standard compositions that, in agreement with appointed bodies and competent authorities, have been included in the amendment. The amendment contains 20 standard formulas for cement, one for gypsum binder and two for ready-mixed concrete. The list of formulas is exhaustive and only mixtures matching those found in the amendment can deviate from the harmonised information requirements.

Companies can refer to the relevant standard formula when compiling their notification. To benefit from this solution, the mixture composition has to conform with the standard formula. In this way, it can be ensured that the poison centres are able to give accurate emergency health response information if there is an accident.

If a safety data sheet (SDS) of the mixture contains more detailed information than the standard formula, the submitter must use the information from the safety data sheet in their poison centre notification.

 

Natural variation in composition of fuels – refer to safety data sheets

Since fuels are normally formulated from naturally occurring substances, their composition can also vary. This means that although the product may be considered to be technically the same, the chemical composition between different batches can differ. If all variations and different compositions would be treated as different mixtures, the formulators would need to submit frequent notifications and multiple UFIs that refer to essentially the same product placed on the market.

According to the amended legal text, formulators can use the information available in the safety data sheet when submitting the compositional information. To make sure that poison centres can sufficiently identify the composition in an emergency, the notification must also include any other known information on the product’s chemical composition even if this information is not included in the SDS.

 

Using multiple suppliers – interchangeable group solving the issue

Sometimes a mixture may contain different components that are toxicologically very similar and possibly have the same technical function. This can be the case, for example, when a component fulfilling a particular technical function is purchased from different suppliers to guarantee the continuity of the supply. In this situation, it may be difficult to know exactly which components are included in each batch of the final product and what their concentration is, which will make it difficult to meet the standard harmonised information requirements for components.

The amendment allows formulators to group toxicologically similar components of a mixture together and include the total concentration of the different components in their notification, instead of specifying separate concentrations for each component.

Components with identical hazard classification can be grouped in the same interchangeable component group if they have either:

• the same toxicological profile and same technical function in the final mixture; or
• a similar pH value – although not necessarily the same technical function.

The variation of components in the interchangeable group cannot affect or change the classification and labelling of the final mixture placed on the market.

Any industry sector can benefit from the concept of interchangeable group.

 

Compliance dates remain unchanged

Although there have been requests to further postpone the first compliance date, this amendment does not introduce any changes to the dates already modified by a former amendment. The compliance dates remain as follows:

• Mixtures for consumer use and mixtures for professional use need to be notified from 1 January 2021.
• Mixtures for industrial use need to be notified from 1 January 2024.
• End of the transition period 1 January 2025.

The Commission decided not to further postpone the first compliance date, because ECHA’s notification tools are available and already being used by companies.

ECHA is currently updating the Guidance on harmonised information relating to emergency health response and its progress can be followed on ECHA’s web pages for ongoing guidance consultations. The final version is estimated to be ready around May 2021.

 

Further information:

Second amendment

Ongoing guidance consultations

Presentation: Staying on top of your obligations [PDF] [EN]

Practical solutions to help meet harmonised information requirements, News release 2 September 2020

 

Text by Päivi Jokiniemi

Published on: 29 September 2020

Top image: © Pixabay/Gerd Altmann

 

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