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Notification requirements

Article 45 of CLP Regulation (EC) No. 1272/2008 (that will replace the Dangerous Preparations Directive 1999/45/EC) states that each European Member State must appoint an authority where information regarding hazardous mixtures must be notified. The appointed authority is responsible for supplying information intended for medical purposes of a curative and preventive nature.

In the Netherlands, the National Poisons Information Centre (NVIC) is appointed in the Food and Drug Act Registration of Product Information (Staatsblad 1996, no. 38) as the competent authority to receive information of hazardous products.

Those introducing hazardous products on the market (both existing and new) are obliged to notify information with the NVIC. Additionally, changes in name and changes in composition need to be notified. Notification of date of market withdrawal is voluntary. The implementation of the Act within industry will be checked by the Food and Consumer Product Safety Authority.

With several Dutch trade organisations new guidelines on the required composition information and on the product information format were established (see below). These guidelines came into force with the Food and Drug Act ‘Warenwetregeling elektronische productnotificatie’ (Staatscourant Nr. 15507 of 15 Oktober 2009).

Information of products not classified as hazardous can be notified on a voluntary basis.

New guidelines for product notification
An agreement was reached on both the required format of the product information and about the requirements on the composition of the notified products.

On the required format it was decided to accept:

  • a Material Safety Data Sheet (MSDS) with
  • additional information on the composition of the product
    (see below for requirements)

The MSDS and the additional information can either be supplied as two separate documents or combined in an improved MSDS. It is also still possible to use a Product Information Sheet. It is obligatory that these documents meet the requirements on composition and concentration as indicated below.

Furthermore, all these documents can only be supplied as PDF-files. Other file formats (Word, Excel, etc.) will not be accepted.

On the requirements on the composition of the product it was decided to stress the importance of detailed information but to also define the minimum requirements.

Companies should be aware that detailed information on the composition of a product is essential to perform an adequate risk assessment in case of an accidental intoxication with their product.

Optimal requirements:

  • Exact composition: all ingredients without concentration threshold
  • Exact concentrations of all ingredients

Alternative requirements:

  • Exact composition: all ingredients without concentration threshold
  • Exact concentration for ingredients in hazard class: T+, T, C, Xi, Xn
    Translated in EU-GHS this corresponds to all health hazard classes.
  • Defined concentration ranges (see below) for the other ingredients

Minimum requirements:

  • Exact composition: all ingredients without concentration threshold
  • Defined concentration ranges:
    <0,1%, 0,1-1%, 1-5%, 5-10%, 10-20%, 20-30%, 30-50%, 50-75%,75-100%
    Alternative: <0,1%, 0,1-1%, 1-5%, 5-10%, 10-15%, 15-30%, 30-60%,60-100%

The internationally accepted chemical names for the ingredients must be used with the corresponding CAS-numbers.

Mentioning EINECS numbers and the hazard classification of each ingredient is optional, but valued.

In exceptional cases products can be notified in groups. For example with paints of different colours and almost the same composition.

Note: with every mutation in product information it is necessary to both renotify the SDS and the additional information (if two separate documents are supplied).