REACH Testing (for EU compliance)

Introduction

In the European Union (EU), the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation is a comprehensive legislation designed to ensure the safe use of chemicals and protect human health and the environment. Implemented in 2007, REACH has a significant impact on businesses operating within the EU, as well as those exporting chemical substances or products to EU markets. Here, we are going to provide an overview of REACH testing, certification, and the key requirements for compliance…

What is REACH?

REACH is a regulation adopted by the European Parliament and the Council of the European Union with the primary objective of improving the understanding of chemicals’ properties and their potential risks. It places the responsibility on manufacturers, importers, and downstream users to identify and manage the risks associated with chemical substances that are often used in the manufacturing and assembly of products.

Scope and Applicability

REACH applies to substances manufactured or imported into the EU in quantities of one tonne or more per year. It covers a wide range of substances, including chemicals used in industrial processes, consumer products, and even substances in articles such as textiles, furniture, and electronics. For a full list of restricted substances, click here.

Restricted substances

The following examples are not exhaustive and the substances restricted under REACH are subject to change so more may be added over time:

Substances of Very High Concern (SVHC)

There are around 200 or so SVCH at present under REACH, so not all will be listed here, however, these are some examples:

• Bisphenol A (BPA)
• Lead and lead compounds
• Cadmium and cadmium compounds
• Formaldehyde
• Specific phthalates
• Various substances classified as carcinogens, mutagens, or reproductive toxicants (CMRs)
• Dichloromethane (Methylene chloride)
• Nonylphenol ethoxylates (NPEs)
• Benzo[a]pyrene
• Cobalt and its compounds
• 4,4′-Diaminodiphenylmethane (MDA)
• Tris(2-chloroethyl)phosphate (TCEP)
• Diisobutyl phthalate (DIBP)
• Diarsenic trioxide
• Perfluorooctanoic acid (PFOA)
• Diethylhexyl phthalate (DEHP)
• Lead chromate
• Hexabromocyclododecane (HBCDD)
• Bis(2-ethylhexyl) phthalate (DEHP)
• Cadmium oxide
• N,N-dimethylformamide (DMF)
• Tetrabromobisphenol A (TBBPA)
• Benzyl butyl phthalate (BBP)
• Trichloroethylene (TCE)
• Ammonium dichromate
• Arsenic acid

Annex XIV Substances (Authorization List)

• Chromium trioxide
• Diisocyanates (e.g., Toluene diisocyanate)
• Selected phthalates
• Some perfluorinated compounds (e.g., perfluorooctane sulfonic acid, PFOS)

Restriction List (Annex XVII)

• Asbestos fibers
• Specific polycyclic aromatic hydrocarbons (PAHs)
• Some phthalates for use in toys and childcare articles
• Mercury and mercury compounds in certain measuring devices
• Specific brominated flame retardants (e.g., DecaBDE)

Read the full list of restricted substances 👉 click here to check them on the EU’s own resource.

REACH Testing

Importers of products into the European Union (EU) are required to test for the presence of banned or restricted substances. These substances are known to be hazardous to human health or the environment, and their presence in products can lead to serious consequences.

When testing for banned or restricted substances, labs typically focus on the SVHC substances that are most likely to be present in the product. For example, if the product is a plastic part, the lab will likely test for phthalates. Phthalates are a group of chemicals that are used to soften plastics, and they have been linked to a number of health problems, including reproductive problems, developmental problems, and cancer.

If the product is a metal part with plating, the lab will likely test for nickel and lead. Nickel and lead are two metals that are commonly used in plating, and they can be harmful to human health if they are present at high levels.

The specific SVHC substances that are tested for will vary depending on the type of product being imported. However, by focusing on the substances that are most likely to be present, labs can help to ensure that products imported into the EU do not contain any banned or restricted substances.

Types of tests performed on products undergoing REACH testing

The types of tests that are conducted under REACH vary depending on the specific chemical substance being tested for. However, some of the most common tests include:

• Toxicity testing: This type of testing is used to assess the potential of a chemical substance to cause harm to living organisms. Tests may be conducted to assess the acute toxicity (short-term effects) or the chronic toxicity (long-term effects) of the chemical substance.
• Ecotoxicology testing: This type of testing is used to assess the potential of a chemical substance to harm the environment. Tests may be conducted to assess the effects of the chemical substance on aquatic organisms, soil organisms, or other environmental compartments.
• Persistence and bioaccumulation testing: This type of testing is used to assess the potential of a chemical substance to persist in the environment and to accumulate in living organisms. These tests are important because they can help to identify chemicals that have the potential to cause long-term environmental damage.

Measures taken following testing results being obtained

The results of REACH testing are used to assess the risks associated with a chemical substance and to develop appropriate risk management measures. These measures may include:

• Labeling requirements: Labels on products containing chemical substances must include information about the hazards of the substance and how to handle it safely.
• Use restrictions: Some chemical substances may be restricted from use in certain applications, such as in consumer products or in the workplace.
• Phase-out requirements: Some chemical substances may be phased out of use over time, as safer alternatives become available.

REACH testing is an important part of the REACH Regulation, which is designed to protect human health and the environment from the risks posed by chemicals. The results of REACH testing help to ensure that chemicals are used safely and that risks are managed effectively.

Here are some additional tips for importers of products into the EU:

• Check the ECHA website regularly to stay up-to-date on the latest list of banned and restricted substances.
• Work with a reputable lab that has experience testing for banned and restricted substances.
• Get the test results in writing and keep them on file for future reference.

Common SVHC tested for in the EU

Here are some of the most common SVHC (Substances of Very High Concern) substances tested for in Europe:

• Phthalates: Phthalates are a group of chemicals used in plastics, such as PVC, to increase flexibility. Some phthalates, like DEHP, DBP, BBP, and others, have been identified as SVHCs due to their endocrine-disrupting properties and potential adverse effects on human health and the environment.
• Bisphenol A (BPA): BPA is commonly used in the production of polycarbonate plastics and epoxy resins. It has been classified as an SVHC due to its endocrine-disrupting properties.
• Polybrominated diphenyl ethers (PBDEs): PBDEs are flame-retardant chemicals used in various consumer products, electronics, and textiles. They have been identified as SVHCs due to their persistence, bioaccumulation, and potential for long-range transport in the environment.
• Lead: Lead is a heavy metal that has been extensively used in various applications, including electronics, batteries, and certain paints. It is an SVHC due to its toxicity to human health and the environment.
• Cadmium: Cadmium is another heavy metal used in alloys, batteries, and certain coatings. It has been classified as an SVHC due to its toxicity and environmental impact.

Key points to remember about REACH testing

Manufacturers need to remember these points about REACH testing:

• REACH testing is required for all chemical substances that are manufactured or imported into the European Union in quantities of 1 tonne or more per year.
• The types of tests that are conducted under REACH vary depending on the specific chemical substance being tested.
• The results of REACH testing are used to assess the risks associated with a chemical substance and to develop appropriate risk management measures.
• REACH testing is an important part of the REACH Regulation, which is designed to protect human health and the environment from the risks posed by chemicals.

They usually test for the presence of banned or restricted substances. And the testing lab usually focuses only on the SVHC substances that are likely to be present. For example, if there is a plastic part, look for phthalates. If there is a metal part with plating, look for nickel, lead, etc.

Pre-test Lab Requirements

In order to make REACH testing as easy as possible, you would need to provide key information to the test lab prior to tests being carried out. This information will assist the lab understand what tests need to be carried out based on the chemicals or heavy metals included in your product.

Here is a summary of what information a test lab would require a manufacturer prior to testing their product:

• Intended use of the product: used to assess the potential exposure of humans and the environment to the chemical substance.
• Composition of the product: used to determine the presence of any hazardous substances and to assess the potential risks associated with the product.
• Manufacturing process: used to identify any potential hazards associated with the manufacture of the product.
• Exposure assessment: used to assess how humans and the environment are exposed to the chemical substance.
• The safety data sheet for the product: this document provides information about the hazards of the product and how to handle it safely.
• Any previous testing data: can be used to assess the risks associated with the product and to identify any gaps in the testing data.
• Any published scientific literature: can be used to identify any potential hazards associated with the product and to assess the risks associated with the product.

By providing this information to the test lab, the manufacturer can help to ensure that the product is tested safely and that the results of the testing are accurate.

Key Requirements for Compliance with REACH

To obtain REACH compliance, businesses must fulfill the following obligations:

1. Registration: Manufacturers and importers must register substances with the European Chemicals Agency (ECHA) if they are produced or imported in quantities exceeding one tonne per year. The registration includes information about the substance’s properties, uses, and guidance on its safe handling and risk management.
2. Evaluation: ECHA and EU member states evaluate selected substances to ensure compliance with REACH requirements. This evaluation may involve requesting further information from registrants or conducting additional testing if concerns about a substance’s properties or uses arise.
3. Authorization: Certain substances of high concern, such as carcinogens or substances that persist in the environment, require authorization to be used. Businesses must apply for authorization to continue using these substances, and alternatives should be sought whenever possible.
4. Restriction: The REACH regulation restricts the use of certain hazardous substances in order to minimize the risks they pose to human health and the environment. This has led many importers to test their products for the presence of these substances, as they are required to comply with REACH regulations.
5. Communication in the Supply Chain: Downstream users of chemicals have a crucial obligation to effectively communicate vital information about the safe handling and use of these substances throughout the supply chain. This includes providing customers with pertinent details, such as safety data sheets and instructions for safe use. This communication is especially important for products that may be recycled, as the chemicals they contain could pose a risk to human health and the environment if not handled properly. The significance of this communication is set to increase significantly with the implementation of the Ecodesign for Sustainable Products Regulation, which will require manufacturers to provide more information about the chemicals used in their products.

REACH testing products for substances of very high concern is a key requirement for virtually all non-food consumer goods. Including the test results in the technical file, which serves as evidence of the products’ adherence to the stringent requirements of the REACH directive, will help importers demonstrate compliance to the Customs and Market Surveillance Authorities. 

Cost of REACH Testing

Let’s take a wristwatch as an example product that needs to be tested in order to obtain a lab report.  The cost of REACH testing for a watch can vary depending on the specific watch and the tests that are required. However, as a general rule of thumb, the cost of REACH testing for a watch can range from a few hundred euros to several thousand euros.

Here is a breakdown of some of the factors that can affect the cost of REACH testing for a watch:

• The complexity of the watch: The more complex the watch, the more tests that may be required. This can increase the cost of testing.
• The materials used in the watch: The materials used in the watch can also affect the cost of testing. For example, if the watch contains a metal that is known to be hazardous, then additional testing may be required.
• The location of the testing laboratory: The location of the testing laboratory can also affect the cost of testing. Testing laboratories in the European Union tend to be more expensive than testing laboratories in other parts of the world.

Here are some examples of the cost of REACH testing for a watch:

• A simple watch that contains a few basic materials may cost a few hundred euros to test.
• A more complex watch that contains a variety of materials and requires a number of tests may cost several thousand euros to test.
• A watch that contains a hazardous material may require additional testing, which can increase the cost of testing.

It is important to note that these are just examples, and the actual cost of REACH testing for a watch will vary depending on the specific watch and the tests that are required.

Benefits of Compliance with REACH

Complying with REACH and doing REACH testing offers several benefits, including:

1. Ensuring Human Health and Environmental Safety: By identifying and managing the risks associated with chemical substances, REACH contributes to safeguarding human health and protecting the environment from harmful effects.
2. Enhancing Market Access: Compliance with REACH is a prerequisite for accessing EU markets, giving businesses a competitive advantage and facilitating trade within the EU.
3. Building Trust and Reputation: Demonstrating commitment to REACH compliance enhances a company’s reputation, instilling confidence in customers, regulators, and stakeholders.

Conclusion

The REACH EU Regulation plays a crucial role in ensuring the safe use of chemicals, protecting human health, and preserving the environment. Businesses involved in manufacturing, importing, or using chemical substances must comply with the registration, evaluation, authorization, and restriction requirements outlined by REACH. By fulfilling these obligations and doing REACH testing, companies can not only meet legal requirements but also demonstrate their commitment to responsible chemical management and gain a competitive edge in the EU market by showing their products have a REACH certification.

Further reading about REACH

For more detailed information on REACH testing and the regulation itself, you can visit these websites:

• European Chemicals Agency (ECHA): The official website of ECHA provides comprehensive information on REACH regulations, compliance requirements, and guidance documents. You can refer to specific sections or publications on their website: https://echa.europa.eu/
• European Union: The Europa website of the European Union offers official information and resources related to REACH, including the full text of the regulation, updates, and guidance documents: https://europa.eu/
• 11 Common Electronic Product Certification And Compliance Requirements: Explore the real world of 11 common compliance requirements for electrical/electronic products and gain further insights into their meanings, methodologies and test requirements.

Disclaimer…

We are not lawyers. What we wrote above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.