Helsinki, 28 June 2017- European Chemical Agency officially published the fourth version of guidance on requirement for substance in articles. The updated guidance includes amending examples in line with the judgement of the Court of Justice of 10 September 2015, which further clarified the scope of the obligations. According to the ruling, the legal obligations also apply to articles that are present in complex products – for example, a component of a car or a washing machine. As it said, the 0.1% threshold for notifying SVHCs in articles applies to each of them. Echa also updates and improves the existing examples, thanks to experience gained and questions received.
This guidance will be useful for companies that import and produce articles. It clarifies their obligations under REACH to communicate with customers and notify ECHA when substances of very high concern (SVHCs) are contained in the article. SVHCs are listed on the Candidate List. It will also help them to make sure that they have sufficient information to comply with their respective obligations.
Obligations described in the present guidance | |||
legal basis in REACH Regulation | Article 7(1) | Article 7(2) | Article 33 |
actors concerned | article producers and article importers | article producers and article importers | article suppliers |
substances concerned | substances intended to be released from articles | substances included in Candidate List of Substances of Very High Concern for authorisation | substances included in Candidate List of Substances of Very High Concern for authorisation |
tonnage threshold | 1 tonne per year | 1 tonne per year | - |
concentration in article threshold | - | 0.1% (w/w) | 0.1% (w/w) |
exemption from obligation possible on the basis of: | |||
substance already registered for that use (Art. 7(6)) (subchapters 3.3.1 and 4.3.2) | yes | yes | no |
based on “exclusion of exposure” (Art. 7(3)) (subchapter 3.3.2) | no | yes | no |
In the Article 3(3) of Guidance on requirements for substances, article is defined as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition.
Deciding whether an object is an article | ||
Chapter 2.2 | Example 1: Blasting grit Example 2: Postcard | To show thatphysical propertiesthat result from the chemistry of the material(s) the object is made of should not be confused with the shape, surface or design of the object. |
Chapter 2.3 | Example 3: Wax crayon | To give a simple case on how todistinguish a mixture from an article, taking into account the function of the object. |
Chapter 2.3 | Example 4: Printer cartridge | To illustrate the application of a first tier of indicative questions (step 4 of the flowchart in figure 2) to decide whether an object is a combination of a substance/mixture and an article. |
Chapter 2.3 | Example 5: Thermometer | To illustrate the application of a second tier of indicative questions (step 5 of the flowchart in figure 2) to decide whether a substance/mixture is an integral part of an articleor a combination of that substance/mixture and an article. |
According to the Version 4.0, the full revision of the guidance addresses structure and content of the parts dealing with the notification and communication obligations regarding candidate list substances. Compared with the former version(version 3.0), the structure has been generally reviewed to render the document clearer, more readable, and more user-friendly.
C&K Testing reminds，it has been the foregone conclusion that requirement on SVHC content for complex articles, based on component calculation. As the products with multitudinous components like a car, the integrated SVHC testing for complete articles will be costly, which increase the cost of responding to the SVHC. C&K Testing suggest, enterprises pay attention to information communication in the whole production process and take control of SVHC risk in articles. Meanwhile, it is essential to do targeted testing.
|Further Information:
1. ECHA official information
2. Guidance on requirements for substances in articles version 4.0
3. ECHA plans to update guidance on substances in articles - C&K Testing reported in October 2015
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