

Material compliance plays an important role in the European Union (EU), as it needs to guarantee user safety in particular, as well as protecting the environment. The EU has introduced a number of regulations and pieces of legislation to ensure that companies manufacture their products on the basis of current knowledge, with the least possible risk to health and environment.
The central instrument is the REACH Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) including the SCIP database (Substances of Concern in Products), which aims to restrict the use of hazardous chemicals and promote the exchange of information throughout the supply chain. In addition, there are special regulations such as the RoHS Directive (Restriction of Hazardous Substances in electrical and electronic equipment).
For companies that want to sell their products in the EU, it is important to adhere to these provisions in order to avoid possible legal consequences such as product recalls, fines, or imprisonment and gain user trust in their products.
Questions we’ve advised companies on in the past:
Does RoHS apply to our product, even if it’s only a component of an electronic device?
How do we know whether our products contain prohibited substances?
Do we have to add every product to the SCIP database?
RoHS 3 doesn’t exist yet. EU Directive 2015/863 is one of more than 80 directives amending RoHS 2. So declarations of conformity for Directive (EU) 2015/863 alone are not sufficient.
Component manufacturers take note: Even if you only produce plastic casings – if they are built into an electrical or electronic product, you’ll need to adhere to RoHS levels.
A. Rösslein, Expert Product Compliance, Stäubli Electrical Connectors AG
The RoHS Directive is an important regulation for electrical and electronic devices that are to be sold in the European Union. RoHS stands for “Restriction of Hazardous Substances” and aims to restrict the use of certain hazardous substances in these products.
The aim of the RoHS Directive is to help protect human health and the environment by restricting the use of hazardous substances in electronic and electrical devices.
Since July 22, 2019, the open scope applies. This means that all electrical and electronic products will have to fulfill the requirements, unless they are generally excluded under Article 2 (4) of this Directive.
In accordance with the Directive, manufacturers and importers must ensure that their products do not contain more than the specified levels of certain hazardous substances.
The completed and compliant electrical or electronic device must be labelled with a CE mark and an EU declaration of conformity must be issued.
Annex II of the RoHS Directive lists the currently restricted substances with the maximum allowed concentrations in brackets.
Lead (0,1 %)
Mercury (0,1 %)
Cadmium (0,01 %)
Hexavalent chromium (0,1 %)
Polybrominated biphenyle (PBB) (0,1 %)
Polybrominated diphenyl ethers (PBDE) (0,1 %)
Di(2-ethylhexyl) phthalate (DEHP) (0,1 %)
Butyl benzyl phthalate (BBP) (0,1 %)
Dibutyl phthalate (DBP) (0,1 %)
Diisobutyl phthalate (DIBP) (0,1 %)
The concentrations always refer to the homogeneous material, meaning a material that cannot be mechanically separated into different materials.
It must be noted that all components and materials used in or built into an electrical or electronic device must meet RoHS requirements – from resistors and plugs to casings. So if components are built into electrical or electronic products, then the component manufacturers are also subject to RoHS requirements.
Note:
On March 31, 2015, Delegated Directive (EU) 2015/863 added four phthalates (plasticizers) to Annex II of 2011/65/EU. This is one of 80 delegated directives (at time of writing) to amend Directive 2011/65/EU (RoHS 2), which still exists and must be complied with. At time of writing there is not yet a RoHS 3.
Some of the substances cannot currently be substituted in certain applications. Exemptions to the RoHS Directive 2011/65/EU are listed in Annexes III and IV.
For manufacturers and importers, the biggest challenge here is not just getting the information about which exemptions exist. They also need to find out whether those exemptions actually apply to them.
The length of the exemption period granted depends on the availability of substitute products and the socioeconomic effects. Renewal requests must be submitted to the European Commission at least 18 months before the exemption expires. Rejected renewal requests cannot be resubmitted. In such cases, the exemption expires a minimum of twelve months and a maximum of eighteen months from the date of the decision. The timeliness and availability of the exemptions are published on the Commission’s website.
For many of the exemptions, establishing your own compliance requires you to determine the device category in accordance with RoHS Annex I, if the time limits differ by category. Assigning the category and obtaining the information about exemptions used, as well as checking their validity, is critical for product compliance.
The REACH Regulation is one of the European Union’s most important pieces of material compliance legislation. REACH stands for “Registration, Evaluation, Authorization, and Restriction of Chemicals” and aims to protect health and the environment from the risks posed by chemical substances.
The REACH Regulation is a European Union regulation that has been growing continually since 2006. It serves to identify and register, evaluate, authorize and restrict hazardous substances. It applies to all chemical substances and compounds in products. It covers both private and industrial applications, and therefore involves most of the companies in the EU.
The REACH Regulation gives companies various obligations. They must inform the European Chemicals Agency (ECHA) of the risks posed by the substances and, if required, inform users about how to deal with them safely.
The core elements of the REACH Regulation are:
There are currently over 230 entries on 476 substances on the candidate list, which can be found on the website of the European Chemicals Agency (ECHA).
» To the candidate list
The duty of companies to provide information about these substances in products at concentrations above 0.1 %, as set out in REACH Article 33, is linked to the candidate list. The declaration level is the homogeneous material in a product. This means a material that cannot be mechanically separated into different materials.
Here, the Judgement of the European Court C-106/14 of September 10, 2015 applies. This states that a once-manufactured product that is integrated into a more complex product continues to be a reference for the concentration limit of the chemical substances it contains (“once an article, always an article”). Therefore, the 0.1 % limit does not refer to the finished complex final product.
The only exemptions to the REACH Regulation are:
and additional application areas that are regulated by other legislations.
An important element of material compliance in the EU is the SCIP database. SCIP stands for “Substances of Concern in Articles as Such or in Complex Objects (Products)” and was introduced as part of the Waste Framework Directive 2008/98/EC. The SCIP database serves as a central platform for the exchange of information on substances of very high concern (= SVHC) in products. In accordance with REACH Article 33, manufacturers, importers, and suppliers are obliged to send information about SVHC contained in their products to the SCIP database.
The integration of the SCIP database into the material compliance process is mandatory for companies in order to meet their obligations as laid down by substance legislation requirements. Providing comprehensive information about SVHC in their products allows companies not only to help keep improving the safety of users and the environment, but also to maintain their business operations in the EU.
Are you missing up-to-date information on material compliance provisions for your international target markets?
Do you have too little time and capacity to procure this important information?
Can you really judge whether the researched information comes from official sources and is up to date?
Efficient knowledge management:
We help you determine and understand the statutory requirements that apply in your target markets and keep them up to date.
Material check and substance inventory:
We support you in identifying and documenting the materials used in your products.
Targeted decision-making:
We advise you on risk assessment and how to develop a material compliance strategy.
Effective process optimization:
We guide you through the implementation of helpful material compliance processes, including documentation and staff training.
Smart supplier management:
We help you execute efficient supplier surveys and handle customer requests.
Don’t hesitate to get in touch with our material compliance experts if you have questions or want to discuss a particular concern.
Please describe what you want to talk about in as much detail as necessary and as briefly as possible. You can also attach related files if required.
We look forward to advising you!
B.A.
Linda Kritzler
Material & Environmental Compliance Consultant
Our team of experts can also provide specialist support for your material compliance challenge.
Please send your request using the form here, or give us a call:
+49 30 3229027-50