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registration evaluation authorisation restriction
 

Demands on Downstream Users

Downstream users are not affected to the same extent by the REACh Regulation rules. The downstream user commitments are described in more detail in Title IV of the Regulation.

Registration Obligation

Contrary to manufacturers and importers downstream users do not have to register the substances they use. However, downstream users do have to register substances they import into the EU themselves. In this case, the downstream user is acting as importer and must fulfil the demands placed on importers.

 

It is further possible to envisage a situation where it is impossible to find a supplier willing to register a substance which the recipient user has identified as being critical. The downstream user is then confronted with a situation where he has to decide whether he will register the substance himself in order to guarantee the availability of the substance to his company or whether he will use an alternative substance which will be registered by the respective supplier.

Implementing the Terms of the Safety Data Sheet

Registered substances may only be used for those purposes stated in the safety data sheet as being so-called “identified uses”. Should the downstream user discover that his intended usage is not stated in the safety data sheet then he has to inform the supplier - which is also in his own interest - so that the latter can include the purpose in the safety data sheet. The supplier is under no obligation to do this, particularly if he has concerns regarding the safe usage of the substance. Consequently, the downstream user must then inform the ECHA of his intended usage and may be required to compile a chemical safety report. The downstream user must on all accounts inform the Agency if he is not required to compile a chemical safety report due to specific exemptions.

 

The safety data sheet also contains information on risk minimising measures. In an extended safety data sheet (eSDS) exposure scenarios including usage conditions and risk minimising measures are also described for the identified uses. The downstream user is required to implement these risk minimising measures. In doing so he must check whether the situation described in the safety data sheet applies to his company, whether the measures listed are sufficient in his case or whether further measures are necessary.

 

In future, authorisation details as well as information on manufacturing and application restrictions will also be available in the safety data sheet. Downstream users must observe the authorisation and restriction terms during usage. The use of a substance which has not been registered is forbidden. In any event, the Agency has to be informed about the use of an authorised substance.

Information within the Supply Chain

The downstream user must pass on information to both his suppliers and his customers. In particular, the user should, in his own interest, inform the previous actor in the supply chain about both his applications of a substance and those of his customers so that these can be included in the safety data sheet. The previous actor may be the actual manufacturer, the importer, dealer or another downstream user. Should he fail to comply, the downstream user may be subject to further obligations - from possibly having to compile his own chemical safety report to having to register a substance or raw material important to his company himself.

 

Every prior actor in the supply chain is obliged to pass on information to those actors following in the supply chain - and vice versa

urthermore, the downstream user must also support the manufacturer or importer during the registration process in as far as he must provide the latter with information about any risks to human health or the environment known to him caused by the substance. If the downstream user has gained knowledge during his daily operations or from his customers which may have an effect on the risk evaluation of a substance, or challenge the previous evaluation, he must pass on the information to the previous actor in the supply chain.

 

Of course, the downstream user must also supply the next actor in the supply chain with all the respective safety information and - if necessary - a safety data sheet on his products - be they preparations or produced units. He must ensure that all the information available to him regarding the risks related to the substance can be passed on down right through to the last link in the supply chain. The information must also include those risks resulting from the interaction of the substance with other ingredients contained in the product.