From 5 January 2021, the producer or importer of articles marketed in the EU and containing SVHCs in a concentration > 0.1 wt% need to be notified to the European Chemicals Agency
This post informs you of new requirements to notify articles (eg machine parts) that contain substances of very high concern to the European Chemicals Agency.
Articles within the chemical regulatory framework
Chemical supply legislation, such as the REACH Regulation and the CLP Regulation, divide chemicals into three simple categories:
- Substances: often neat chemicals, as they are manufactured, comprised of one chemical structure. These are called mono-constituent substances. However, substances can also be multi-constituent, or substances of unknown, variable, complex or biological composition (UVCB).
- Mixtures: a deliberate mixture of two or more substances.
- Articles: an object with a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
There has been much debate on the boundary criteria for articles, and how everyday objects are described. For example, a candle is regarded as an article (the wick), embedded in a mixture (the wax plus other ingredients), while liquid thermometers and batteries are articles. The European Chemicals Agency (ECHA) has provided further guidance and examples .
Complex objects are products made up of more than one article. These include most everyday items such as bicycles and electronic equipment.
What are SVHCs?
These are substances of very high concern. SVHCs are defined in Article 57 of the REACH Regulation, and include:
- Substances expected to cause cancer, transmissible genetic defects, or reproductive or developmental effects in humans (collectively known as CMRs);
- Substances meeting the criteria for classification as PBT or vPvB substances. These are long-lasting chemicals that accumulate in animal tissues;
- Endocrine disruptors;
- Other substances of equivalent level of concern to the above.
SVHCs face regulatory actions such as restriction and banning of the substance for some or all uses.
Suspected SVHCs are listed on the Candidate List (mentioned in REACH, Art 59.1), and after further evaluation may be subject to the Authorisation process. Substance on the Authorisation list (REACH Annex XIV) can only be used if the European Chemicals Agency (ECHA) gives dispensation to use it for specific purposes under controlled conditions, with the aim of encouraging substitution of SVHCs with safer alternatives.
New substances are added to the Candidate List, usually twice a year.
Obligations for suppliers of articles containing SVHCs
In the legislation, manufacturers of articles are called producers. The REACH Regulation (1907/2006) gives obligations to producers and importers of articles as follows.
Registration (REACH Art 7.1)
If articles are produced or imported that contain greater than 1 tonne/year of any substance (including an SVHC), and the substance is intended to be released from the article, the company has to submit a registration dossier to ECHA.
This situation also triggers a requirement for hazard classification of the substance according to the CLP Regulation (1272/2008).
Notification to ECHA (REACH Art 7.2)
Any producer or importer of articles containing a substance is on the candidate list has to notify ECHA with basic information if the following conditions are met:
- the total amount of substance in the articles is > 1 tonne per year for each producer or importer;
- the substance is present in the articles at > 0.1 wt%.
Hazard classification according to the CLP Regulation (1272/2008) also applies to substances in articles requiring notification.
Communication in the supply chain (REACH Art 33)
A supplier of an article containing a substance on the candidate list at > 0.1 wt% has to provide the recipient with instructions to allow safe use of the article, including the name of the SVHC substance.
On request by a consumer, a supplier of an article containing a substance on the candidate list at > 0.1 wt% has to provide the consumer with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.
In both situations, the relevant information has to be provided free and within 45 days. Some phone apps can automate these requests for consumers (see here).
This safe use information applies to users and consumers, but not to waste operators, which is why the notification to the SCIP database described below is becoming an obligation (see below).
What is the SCIP database?
SCIP stands for Substances of Concern in Products (ie Articles). It is a new EU database of machine parts that contain Substances of Very High Concern (SVHCs).
The database is established for the prevention of waste under the EU Waste Framework Directive .
ECHA aims to increase understanding of the use of hazardous chemicals in articles, thereby promoting:
- reduction of SVHCs in wastes, particularly by encouraging their substation with less hazardous substances
- increased recycling, by informing waste recyclers of which articles contain SVHCs, and those that do not
- transparency for consumers of such articles
- better regulatory control of SVHCs in the future
- better sustainable chemicals as part of the European Green Deal.
From 5 January 2021, suppliers of articles marketed in the EU and containing SVHCs in a concentration > 0.1 wt% need to notify the articles to the European Chemicals Agency (ECHA).
Practicalities of the notification to the SCIP?
The following suppliers of articles need to provide information to ECHA:
- EU producers, and assemblers of complex objects
- EU companies importing articles or complex objects from outside the EU
- EU distributors of articles or complex objects.
Retailers who supply exclusively to consumers do not need to notify to the SCIP database.
A distributor may streamline the process by referencing information already submitted by an upstream EU supplier to avoid reporting the same article twice.
A consultant can submit data to the SCIP database on behalf of a company.
A manufacturer or assembler of an article (the ‘producer’) must determine whether an SVHC is present in a concentration above 0.1 wt% in any article it makes.
An importer of a complex object (ie an article composed of sub-articles, eg electronic equipment) should determine for each article whether an SVHC is present in a concentration above 0.1 wt%.
The producer is best placed to understand the amount of SVHC in an article. EU importers of articles from outside the EU need good communication with their non-EU suppliers to get the required information. Usually this is done by requesting ‘declarations of compliance’ or other administrative methods. Sometimes analysis is required.
The SCIP notification information includes the following details:
- identification of the article;
- the name, concentration range and location of the SVHC present in it
- information on safe use, eg waste management advice.
The information in the SCIP database is made available to waste operators, and to consumers on request. Some commercial information can be kept confidential.
Information on articles containing SVHCs (on the Candidate List) in a concentration above 0.1 % w/w placed on the EU market needs to be notified to ECHA before 5 January 2021. The information should already be available for REACH Article 33 enquiries.
After 5 January 2021, if a substance is newly listed on the Candidate List, the supplier of an article containing the substance should submit a SCIP notification before the next supply or placement on the EU market.
The EU requirement for SCIP notification is given under EU Waste Framework Directive. As it is a Directive, then each Member State of the EU has to produce its own legislation to implement the requirements (in contrast to an EU Regulation which directly acts in each Member State).
The effects of the Directive do not become active until after the end of the GB transition period on 31 December 2020. There are no plans for a GB equivalent of the SCIP database.
GB producers of articles with SVHCs supplying into the EU will have to have the information available, so that their customers will be able complete the SCIP notification.
 Guidance on requirements for substances in articles; ECHA; Version 4.0; June 2017.
 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on Waste (as amended), Article 9.2.