The road to European product notification, part 3 – Concentration specifications of formulations

As before in the national BfR product notification, the concentration specifications of the formulations for the harmonised EU notification will be more precise than those contained in the safety data sheet. According to a statement by the host at the workshop for implementing Annex VIII of the CLP Regulation, the concentration limits were determined in collaboration with specialists from the medical field to be able to deal with the task of providing information in cases of poisoning.

Within this context, I was also interested to find out if the information for the product notification at EU level is more or less precise than the information in the current valid BfR product notification. In the following and last part (Part 4), I will provide a summary on who can still benefit from a BfR product notification in Germany, postponing European notification until 2025.

Concentration specifications of formulations

The specificity required for the notification of components in mixtures is defined in Annex VIII of the CLP Regulation which deals with the implementation and description of the European product notification.

First a positive example: Finding out if an ingredient needs to be specified more accurately or not depends on its classification and is therefore easier to determine than the BfR definition of special substances.

Specificity of the data

Ingredients with one of the following properties must be described more accurately:

• Acute toxicity 1-3
• STOT single exposure 1, 2
• STOT repeated exposure 1, 2
• Skin corrosive 1, 1A – 1C
• Serious eye damage, 1

More specifically, the limits are:

• Equal to or above 25%: maximum concentration range of 5%
• Including 10 – 25%: Range of 3%
• Including 1 – 10%: Range of 1%
• Including 0.1 – 1%: Range of 0.3%
• 0 – 0.1%: Range of 0.1%

All other substances contained in the mixture use the following maximum concentration ranges:

• Equal to or above 25%: Range of 20%
• Including 10 – 25%: Range of 10%
• Including 1 – 10%: Range of 3%
• 0 – 1%: Range of 1%

Annex VIII, Part B, 3.1 also contains a nice anecdote:

If a component does not exist in a mixture, this component shall not be specified.

Brilliant, isn’t it? It’s good to have clear guidelines… But on a more serious note: there is one exception for group notifications and perfumes/fragrances where these do not necessarily have to be contained in all components, which is the reason for this unsurprising note.

Comparison with BfR product notification

The concentration range for the BfR product notification is relative to the concentration included, apart from concentration grades that are used for particularly small values.

To sum up: For concentration ranges below 5% and above 50%, the specificity of the new harmonised notification for substances with their demonstrated hazards is higher than the existing BfR product notification. For ingredients without the hazards or for non-hazardous substances, the concentration ranges in the new notification are wider, which makes it possible to be less specific.

As before, it is of course also possible to specify formulations using the exact concentration value without the range.

Sources: Workshop on implementation of Annex VIII to CLP

Internet presence Poison Centres

Annex VIII to the CLP Regulation (EU 2017/542)