REACH restrics chemicals, heavy metals, and other substances in consumer products sold in the European Union. That being said, different rules apply to substances that are considered as more harmful.
Substances listed in Annex XVII of the REACH regulation are considered to be more harmful and therefore restricted. The restrictions can differ – in terms of limits or an outright ban – depending on the product type and age group.
What is Annex XVII?
Annex XVII of REACH Regulation is a list of hazardous substances, mixtures, or articles that are restricted or prohibited to be used in consumer products placed in the EU market.
The specific restrictions might vary according to the substances and product categories. For example, Annex XVII sets a weekly migration limit for nickel in jewelry, while it restricts some types of phthalates to 0.1% by weight in plasticized materials.
What is the difference between Annex XVII and the SVHC List?
Both Annex XVII and the SVHC Candidate List belong to the REACH regulation and lists chemicals that are deemed to be harmful to human beings or the environment, whose uses are regulated in the EU market.
The main difference between Annex XVII and the SVHC Candidate List is the level of substance control and the specific requirements.
REACH requires that manufacturers and importers selling products containing more than 0.1% by weight of substances in the SVHC Candidate List, must notify the consumers upon request, and provide instructions on the safe use of the products. According to the Waste Framework Directive, in this case, it is also necessary to register the substance in the SCIP database.
On the other hand, the regulation methods of substances that are listed in Annex XVII are more complex. Each substance is subject to different constraints. Some substances are prohibited to be used in any context, such as asbestos, while other substances are limited to certain concentration levels (e.g. phthalates) or weekly migration limits (e.g. nickel).
Also, some substances are restricted for any type of product, while other substances are only restricted for a particular category of products, as we detail in the next sections of this article.
Are Annex XVII substances banned?
While some substances are banned, such as asbestos or PCT, some substances are restricted to a certain amount (e.g. 0.1% by weight) or to a certain migration limit (e.g. 0.5 μg/cm2/week).
For example, the use of nickel is restricted in body piercing objects unless the migration limit of the nickel release from these objects is less than 0.2 μg/cm2/week. However, for articles that are intended to be worn by humans that have direct contact with the skin, such as a bracelet, the nickel migration limit is set to 0.5 μg/cm2/week.
The above example shows how restrictions under Annex XVII might vary according to how much a product containing a given substance is deemed dangerous, according to its use.
Can I sell products that contain Annex XVII substances above the set limits?
Manufacturers, importers, or anyone who places products in the EU market must comply which REACH Annex XVII requirements, including ensuring that the concentration level of regulated substances is kept under the prescribed limit. Thus, products that contain restricted substances above the set limitations, can’t be placed (as in sold) in the EU market.
List of Restricted Substances
Below we list some examples of restricted substances under REACH Annex XVII.
Phthalates are a group of chemical substances that are often added to plastics to improve the flexibility and durability of the products. Currently, REACH Annex XVII restricts the use of some phthalates to a maximum of 0.1% by weight in plasticized materials, including:
Here are some examples of products that might contain restricted phthalates:
- Plastic cutlery
- Plastic wrapping paper
- Jelly rubber toys
- Paint pigments
- Nail polishes
- Medical tubes
Lead and its compounds
Lead and its compounds are substances listed in REACH Annex XVII. Any jewelry article and any product that might reasonably be placed in the mouth by children that contains a concentration of lead equal to or greater than 0.05% by weight is prohibited.
Here are some examples of regulated products that might contain lead:
- Chew toys
Nickel and its compounds
Nickel and its compounds are substances that are included in REACH Annex XVII. The use of nickel is restricted in body piercing objects unless the migration limit of the nickel release from these objects is less than 0.2 μg/cm2/week.
For articles that are intended to be worn by humans for a long time and have direct contact with the skin, nickel migration is set to 0.5 μg/cm2/week. Examples of such articles include:
- Wrist-watch straps
Cadmium and its compounds
Cadmium and its compounds are substances listed in REACH Annex XVII. The maximum allowable concentration level of cadmium that is allowed to be used in plastics is 0.01% by weight of the plastic materials. These plastic materials include but are not limited to:
Metal parts of jewelry that contain more than 0.01% of cadmium by weight are also prohibited in the market. Examples of such jewelry include:
In addition, cadmium and its compounds are prohibited in equipment and machinery for:
- Food production
- Cooling and freezing
- Printing and book-binding
- Household good
- Sanitary ware
Chromium VI compounds
Chromium VI compounds are substances that are listed in REACH Annex XVII. The use of chromium VI compounds is restricted in some products, such as the following:
a. Articles that contain leather coming into contact with the skin should not contain more than 0.0003% of chromium VI by weight of the total dry weight of the leather
b. Hydrated cement and cement-containing mixtures should not contain more than 0.0002% of soluble chromium VI by weight.
Mercury is listed in REACH Annex XVII and its use is restricted in some measuring equipment. For example, mercury is not allowed to be used in devices that are intended for sale to the public such as:
- Fever thermometers
These devices that are intended for industrial or professional uses are also prohibited if these contain mercury:
- Thermometers and other non-electrical thermometric applications
Azocolourants and Azodyes
Azo colorants and azodyes are listed in REACH Annex XVII. The allowable concentration level of azo dyes is 0.003% by weight in textile and leather articles, such as:
- Sleeping bags
- Chair covers
Toluene is a substance that is listed in REACH Annex XVII, which is prohibited to be used in adhesives or spray paints intended for supply to the general public, in a concentration equal to or greater than 0.1% by weight.
Is the Annex XVII list updated?
Any EU Member State or the European Chemicals Agency (ECHA) might propose to add to Annex XVII substances that are deemed to have harmful effects on humans or the environment. These proposals do not take place periodically.
How does the restriction procedure work?
In this section, we summarize the procedure to add a substance to REACH Annex XVII.
The Member States or the ECHA can propose to restrict substance(s) that might pose harm to human health or the environment. The intention of restriction proposal is published in the ECHA’s registry of intentions so as to give an advance warning to the public and interest parties, such as manufacturers or importers.
The proposal dossier should be prepared according to the requirements of REACH Annex XV and must contain information such as:
- Substance identity
- Reasons and explanations for the proposed restrictions
- Identified risks
- Information on alternatives to the substance and the costs
- Environmental and human health benefits resulting from the restriction
If the dossier conforms to REACH Annex XV requirements, it is made publicly available for consultation and comments on the ECHA’s website. At this time, the Committee for Socio-economic Analysis (SEAC) should also prepare an opinion about the socio-economic impacts of the suggested restrictions. In the following 9 months, the ECHA’s Committee for Risk Assessment (RAC) evaluates whether the suggested restriction is appropriate in reducing the risk to human health or the environment based on the dossier and the public comments.
The European Commission considers the opinions of ECHA’s committee and then evaluates the benefits and costs of the proposed restriction.
Within three months after receiving two committees’ opinions, the European Commission should provide a draft amendment to the list of restrictions in Annex XVII to REACH, if the proposal is accepted. The final decision is made involving the Member States and the European Parliament.
Once the restriction has been adopted, Member States must enforce the rules and require manufacturers and importers to comply with them.
How do I know which Annex XVII listed substances to test for?
Our recommendation is that you contact a testing company. When labs quote REACH testing they usually quote Annex XVII testing by default.
You might also want to clarify that they should provide a quote both for Annex XVII substances testing and SVHC testing – but keep the substance list and quotation separate.
Where can I find a complete list of Annex XVII restricted substances?
You can visit the official website of ECHA to browse the complete list of substances under Annex XVII. Keep in mind that new substances can be added to Annex XVII from time to time. Therefore, whether you are a manufacturer or importer, you should keep track of the updates of Annex XVII.