29 March 2019 Published in FAQ Written by 

FAQ from Journal 03/2019

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Question 1:
We use a metal filler in an automotive product. Unfortunately, the manufacturer is not in a position to supply us with a corresponding data record. Reference is only made to the safety data sheets that have been sent to us.

How should we proceed now or what possibility exists to list the used product in the IMDS data record created by us for our customer? What is the general procedure for products for which no IMDS data record is available?

The IMDS General Rules and Guidelines states that material data must be passed along the supply chain. By definition, rules are binding requirements.

FAQ1 01

A further rule states that the materials used must be described in the IMDS in their final state. A safety data sheet does not usually contain this information, as stated in Directive 4.4.1.b.

FAQ1 02

If the manufacturer cannot/does not want to enter the data in the IMDS, we recommend having the material analysed in the laboratory in its final state. The laboratory will announce the composition and this data can then be entered in the IMDS. We will be happy to assist you in establishing contact with a laboratory. Please contact us.

Question 2:
I have a question concerning the information obligation of substances on the SVHC candidate list under Article 33(1) of the REACh Regulation.

Lead has been on the candidate list since the end of June 2018. We have many articles made of a copper alloy with lead >0.1%, so far I have not received any information according to Article 33 paragraph 1 from our suppliers. Normally I should get the information according to article 33 paragraph 1 from our suppliers?

We have suppliers who declare in the IMDS and suppliers in the field of mechanical engineering who do not further declare the material. Is the declaration in the IMDS sufficient and no further information necessary?
According to the O5A principle, a part that can be sold individually is always a part. What’s about the obligation to provide information?

Lead (EC No 231-100-4; CAS No 7439-92-1) was added to the candidate list on 27.06.2018. Since this date two requirements apply for articles according to REACH:

  1. Article 7(2) : Notification to ECHA under certain conditions.
  2. Article 33 : Obligation to communicate information on substances in articles. This concerns your questions.

As soon as a substance on the candidate list with more than 0.1% (mass percentage) is contained in an article, provide your customer with sufficient information for a safe use of the article, at least state the name of the substance concerned.
The REACH Regulation does not say how you should inform your customers. This can be done by letter, e-mail or IMDS. IMDS is well suited for this because this database has been developed specifically for materials. But if your customer does not use the IMDS, you should inform him otherwise (letter, e-mail...).

In your case, since you have more than 0.1% lead in the copper alloy, you must inform your B2B customer immediately.
Example : You buy a copper alloy groove from a supplier. The groove contains 3% lead by weight. You make an assembly from the supplier's groove with a steel screw that you make yourself. To comply with article 33, you should:

  1. be sure that the MDS of your assembly is available to the customer and
  2. provide any information sufficient to ensure safe use of the product. For example: "Wear gloves when handling grooves".

Safe use of the article concerns only the candidate list substance.

REACH applies in the EU. If your supplier is not based in the EU, he has no obligation to inform you about substances on the Candidate List. You remain responsible for the conformity of the composition of the groove according to Article 33. A supplier within the EU must inform you immediately of the information according to Article 33(1). Your supplier is responsible for the conformity of the groove composition according to Article 33.

O5A (Once An Article, Always An Article) is fulfilled by the use of the IMDS in the case of your copper part. Even if the copper part is mounted in an assembly, the information "lead in copper part" is still available to the OEM.

More information can be found on the ECHA website at https://echa.europa.eu/de/candidate-list-obligations.

Question 3:
With my IMDS entry I get the error message "More than 10% undefined pure substances". Can you help me?

FAQ3 01

The error message comes from the large raw material fluctuations.

In your case, for example, 55.0-65.0% polyvinyl chloride, 30.0-36.0% bis(2-ethylhexyl)terephthalate, 1.0-3.0% soybean oil and 0.0-1.0& other additives are given.

In order to avoid error messages, at least 90% of the materials must be declared. For this purpose, the known minimum quantities are added together. So 55.0 + 30.0 + 1.0 = 86.0%. Thus more than 10% are not declared, which leads to the error message. Below you will find the corresponding guideline and a calculation example.

FAQ3 02

FAQ3 03

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Last modified on Friday, 29 March 2019 11:08


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