EU REACH compliance: Heavy metals in articles

This material is for informational purposes and you should not take it as a substitute for legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations concerning your product. This material only reflects the position at the date of writing and requirements across the EU and in the UK may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (see below) to learn more about changes that may affect you following the end of the transition period.

EU Requirements

Regulation (EC) No 1907/2006 (the “EU REACH Regulation”) applies to the sale of heavy metals and their safe use in the EU. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. Under the EU REACH Regulation, manufactures and importers are generally required to collect information on the properties of chemical substances present in their products, which could be subject to registration, authorisation, restrictions or information provision requirements. In addition, distributors can also be subject to REACH restrictions and information provision requirements. It is your responsibility to comply with the EU REACH Regulation. You must also comply with other national requirements in relevant countries.

Please see below for further information about EU requirements. Please also see this page for more information on the sale of chemicals.

UK Requirements

Regulations for the sale and safe use of chemicals

All chemicals first made available in the UK or EU on or before December 31, 2020 need to comply with the EU REACH Regulation. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. Under the EU REACH Regulation, manufactures and importers are generally required to collect information on the properties of chemical substances present in their products, which could be subject to registration, authorisation, restrictions or information provision requirements. In addition, distributors can also be subject to REACH restrictions and information provision requirements.

Chemicals that are first made available in the EU or UK on or before December 31, 2020 can continue to circulate until they reach their end user and do not need to comply with the changes that take effect from January 1, 2021. You can retain evidence of when products were first made available in the UK or EU by keeping documents including contracts of sale, invoices and documents concerning the shipping of goods for distribution.

Chemicals first made available in Great Britain (England, Scotland and Wales, “GB”) after December 31, 2020 will need to comply with an amended version of the REACH Regulation as a result of the REACH etc. (Amendment etc.) (EU Exit) Regulations 2019/758 (the “UK Regulation on Chemicals”). Chemicals first made available in NI after December 31, 2020 will continue to need to comply with the EU REACH Regulation under the Northern Ireland Protocol (see “Northern Ireland” section below).

We have noted below where there will be relevant changes in the requirements following the Brexit transition period.

Please see below for further information about UK requirements. Please also see this page for more information on the sale of chemicals

I. EU Requirements

What is the EU REACH Regulation and how does it apply to products?

When selling products on Amazon, you need to ensure compliance with the EU REACH Regulation. Under the EU REACH Regulation, articles (i.e., finished products) cannot be sold if they exceed limits for certain chemical substances, such as heavy metals. For more information about the EU REACH Regulation, refer to this help page.

Annex XVII n. 23, 27 and 63 of the REACH Regulation sets specific restrictions on the maximum allowable content of cadmium, nickel and lead applicable to articles with metal components:

Substance	Applicable threshold for restriction
Cadmium	equal to or greater than 0.01% by weight
Nickel	rate of nickel release less than 0.2 μg/cm²/week (migration limit)
Lead	equal to or greater than 0.05% by weight

Detailed information on this restriction, along with the complete list of restrictions as listed in the EU REACH Regulation's Annex XVII, is available on the ECHA website. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your product.

How does the EU REACH Regulation impact the products that I sell?

To comply with applicable laws and regulations, Amazon prohibits the sale of articles that exceed the restriction levels specified in Annex XVII of the EU REACH Regulation. For certain products, Amazon requires a REACH declaration from the manufacturer or testing reports showing adherence to the EU REACH Regulation limits for cadmium, nickel and lead. These products include:

• Jewellery and imitation jewellery to put on the wrist and ankle, such as bracelets and anklets
• Jewellery and imitation jewellery to put on the neck, such as necklaces
• Jewellery and imitation jewellery that pierce the skin, such as earrings and piercings
• Jewellery and imitation jewellery that are put around fingers and toes, such as rings and toe rings

In addition, products may be physically tested by Amazon or Market Surveillance Authorities, which could lead to requests for further information or suspension of sales, so it is important for you to have all required compliance documents available for all products in order to request a reinstatement.

How do I request approval or reinstatement of my ASIN?

If your ASIN is jewellery or imitation jewellery, as described above, or has been subject to a physical test and we require additional documentation, you will receive an email with more detailed instructions. In this case, if you want to sell or continue selling these products on Amazon, submit the following information to eu-chemical-safety@amazon.co.uk:

• Company name
• Seller/Vendor ID
• Email address
• Phone number
• The EU marketplaces where you want to continue listing your ASINs
• A list of ASINs you are applying to sell

To speed up the process, submit one application per family ASIN/variation/model number.

Amazon accepts two types of evidence of compliance to approve or reinstate your ASIN:

1. Declaration from the manufacturer of EU REACH Regulation conformity

   This document is a declaration drawn up by the manufacturer confirming the conformity of the product with the EU REACH Regulation. The declaration should also address any Substances of Very High Concern (SVHCs) contained in the product. The declaration can either be signed by the manufacturer or can be issued to the manufacturer by a third-party testing organisation.

2. EU REACH Regulation heavy metals testing reports

   These testing reports show compliance with the EU REACH’s Regulation's heavy metals thresholds for all components of your product (see the following table). If your product failed a physical test by Amazon or a Market Surveillance Authority, we will require a REACH heavy metals testing report.

Table 1. Overview of thresholds and document types

Applicable regulation	Threshold	Type of document
REACH – Annex XVII n. 23, 27 and 63	Cadmium 0.01% (100 mg/kg) Lead 0.05% (500 mg/kg) Nickel has a migration limit 0.2 μg/ cm2/week	Declaration from the manufacturer of EU REACH Regulation conformity; or Testing reports.

All selling partners are responsible for ensuring that their products and listings comply with all applicable laws and regulations. By applying to sell or reinstate these products, you certify that all information you submit is true. You can find a list of external consultants who might help you with questions regarding regulatory requirements on the Service Provider Network page.

Who is responsible for obtaining these documents?

If you are contacted, you are responsible for providing these documents to Amazon. If you are the brand owner or importer, you should already have these documents on hand. If you are a reseller, you may have to ask your supplier for these documents. If you (or your suppliers) do not have these documents available, you may have to undertake testing yourself to demonstrate conformity.

I don’t think my product should have been subject to a document check. Who should I contact?

Contact Selling Partner Support (SPS) for information about why your product was in scope of a document check. If you believe there has been a mistake, SPS can help to file your request to the relevant Amazon team.

Additional information

We strongly encourage you to visit the following sites for more information on the EU REACH Regulation:

• All EU National helpdesks for REACH Regulations: https://echa.europa.eu/support/helpdesks
• European Chemicals Agency (ECHA): https://echa.europa.eu/regulations/reach/understanding-reach

II. UK Requirements

All chemicals first made available in the UK or EU on or before December 31, 2020need to comply with the EU REACH Regulation. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. Under the EU REACH Regulation, manufactures and importers are generally required to collect information on the properties of chemical substances present in their products, which could be subject to registration, authorisation, restrictions or information provision requirements. In addition, distributors can also be subject to REACH restrictions and information provision requirements.

Chemicals that are first made available in the EU or UK on or before December 31, 2020 can continue to circulate until they reach their end user and do not need to comply with the changes that take effect from January 1, 2021. You can retain evidence of when products were first made available in the UK or EU by keeping documents including contracts of sale, invoices and documents concerning the shipping of goods for distribution.

Chemicals first made available in Great Britain (England, Scotland and Wales, “GB”) after December 31, 2020 will need to comply with the UK Regulation on Chemicals. Chemicals first made available in NI after December 31, 2020 will continue to need to comply with the EU REACH Regulation under the Northern Ireland Protocol (see “Northern Ireland ” section below).

What is the UK Regulation on Chemicals and how does it apply to products?

The UK Regulation on Chemicals applies to all chemical substances and mixtures manufactured in or imported into the UK, including articles containing certain dangerous or hazardous chemical substances or mixtures. Under the UK Regulation on Chemicals, articles (i.e., finished products) cannot be sold if they exceed limits for certain chemical substances, such as heavy metals. For more information about this, refer to this help page.

Schedule 3 of the UK Regulation on Chemicals sets specific restrictions on the maximum allowable content of cadmium, nickel and lead applicable to articles with metal components:

Substance	Applicable threshold for restriction
Cadmium	equal to or greater than 0.01% by weight
Nickel	rate of nickel release less than 0.2 μg/cm²/week (migration limit)
Lead	equal to or greater than 0.05% by weight

Detailed information on this restriction, along with the complete list of restrictions is available on the UK Government’s HSE website (see links below). We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your product.

How does the UK Regulation on Chemicals impact the products that I sell?

To comply with applicable laws and regulations, Amazon prohibits the sale of articles that exceed the applicable restriction levels. For certain products, Amazon requires a declaration from the manufacturer or testing reports showing adherence to the UK Regulation on Chemicals limits for cadmium, nickel and lead. These products include:

• Jewellery and imitation jewellery to put on the wrist and ankle, such as bracelets and anklets
• Jewellery and imitation jewellery to put on the neck, such as necklaces
• Jewellery and imitation jewellery that pierce the skin, such as earrings and piercings
• Jewellery and imitation jewellery that are put around fingers and toes, such as rings and toe rings

In addition, products may be physically tested by Amazon or Market Surveillance Authorities, which could lead to requests for further information or suspension of sales, so it is important for you to have all required compliance documents available for all products in order to request a reinstatement.

How do I request approval or reinstatement of my ASIN?

If your ASIN is jewellery or imitation jewellery, as described above, or has been subject to a physical test and we require additional documentation, you will receive an email with more detailed instructions. In this case, if you want to sell or continue selling these products on Amazon, submit the following information to eu-chemical-safety@amazon.co.uk :

• Company name
• Seller/Vendor ID
• Email address
• Phone number
• A list of ASINs you are applying to sell

To speed up the process, submit one application per family ASIN/variation/model number.

Amazon accepts two types of compliance documentation to approve or reinstate your ASIN:

1. Declaration from the manufacturer of UK Regulation on Chemicals conformity

   This document is a declaration drawn up by the manufacturer confirming the conformity of the product with the UK Regulation on Chemicals. The declaration should also address any Substances of Very High Concern (SVHCs) contained in the product. The declaration can either be signed by the manufacturer or can be issued to the manufacturer by a third-party testing organisation.

2. UK Regulation on Chemicals heavy metals testing reports

   These testing reports show compliance with the UK Regulation on Chemicals heavy metals thresholds for all components of your product (see the following table). If your product failed a physical test by Amazon or a Market Surveillance Authority, we will require a UK Regulation on Chemicals heavy metals testing report.

Table 2. Overview of thresholds and document types

Applicable regulation	Threshold	Type of document
Schedule 3 of the UK Regulation on Chemicals	Cadmium 0.01% (100 mg/kg) Lead 0.05% (500 mg/kg) Nickel has a migration limit 0.2 μg/ cm2/week	Declaration from manufacturer of UK Regulation on Chemicals conformity; or Testing reports.

All selling partners are responsible for ensuring that their products and listings comply with all applicable laws and regulations. By applying to sell or reinstate these products, you certify that all information you submit is true. You can find a list of external consultants who might help you with questions regarding regulatory requirements on the Service Provider Network page.

Who is responsible for obtaining these documents?

If you are contacted, you are responsible for providing these documents to Amazon. If you are the brand owner or importer, you should already have these documents on hand. If you are a reseller, you may have to ask your supplier for these documents. If you (or your suppliers) do not have these documents available, you may have to undertake testing yourself to demonstrate conformity.

I don’t think my product should have been subject to a document check. Who should I contact?

Contact Selling Partner Support (SPS) for information about why your product was in scope of a document check. If you believe there has been a mistake, SPS can help to file your request to the relevant Amazon team.

Northern Ireland

Please note that different rules will apply in Northern Ireland (“NI”) from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:

• You should ensure that products meet the requirements of the EU REACH Regulation.
• You should ensure that ECHA has been notified, as required by the EU REACH Regulation.
• Northern Irish businesses that are currently downstream users or distributors may have obligations in relation to chemicals traded from GB to NI.
• Northern Irish businesses may also have obligations to notify GB authorities if placing highly regulated goods in GB.
• “Qualifying Northern Ireland goods” will be able to be sold in GB under unfettered access rights. The UK Government is issuing guidance on how this will work.

BREXIT: UK Government Guidance

The UK Government has released guidance on the sale of chemicals in the UK from January 1, 2021, including on the UK Regulation on Chemicals (as well as CLP, Biocides, Prior Informed Consent and Pesticides or Plant Protection Products).

We encourage you to review this guidance (linked below), alongside any other specific UK Government Guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from January 1, 2021.

• https://www.hse.gov.uk/brexit/chemicals-brexit-guidance.htm
• https://www.hse.gov.uk/brexit/reach-guidance.htm

Additional Information

We strongly encourage you to review the following guidance for more information on the sale of chemicals in the UK.

You can visit the UK Chemicals Helpdesk and review UK Government guidance for more information on REACH, including the following websites:

• https://www.gov.uk/guidance/how-to-comply-with-reach-chemical-regulations

We also encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules:

• https://www.businesscompanion.info/en/get-started