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REACH is an EU regulation restricting chemicals, heavy metals, and pollutants in all products. Products that contain excessive amounts of restricted substances, such as lead or AZO dyes, are illegal to import and sell within the single market.
In this article, I explain how you can determine if REACH testing is necessary for your products, and the steps you must take to properly ensure compliance. That’s why we invited Compliance & Risks, based in Ireland, for help.
In addition, Compliance & risks – a leading product compliance company based in Ireland – answers some of the most common questions importers have about REACH.
What is REACH?
REACH (Registration, Evaluation, Authorisation, and restriction of CHemicals) is a European Union regulation, addressing the production, importing and sales of chemical substances or finished products containing chemical substances.
Well, that’s pretty much everything. As an importer based in an EU country, this means that you are responsible for ensuring the compliance of your products. The responsibility can never be shifted to your Chinese supplier.
The purpose of REACH is to limit human and environmental exposure to certain chemicals (especially those considered highly toxic). While many products are allowed to contain certain chemicals, the amounts are limited. Currently, REACH restricts the usage of more than 1000 chemicals.
Prior to REACH, there were five different chemical directives in Europe. Now they’re all covered by one standard. This certainly makes it easier to ensure compliance.
Which products must be REACH compliant?
REACH restricts the chemicals, heavy metals and pollutants in all consumer products sold in the European Union. As such, REACH is applicable to these product categories:
Products that contain excessive amounts of certain substances are not REACH compliant, and should therefore not be imported and sold within the European Union.
That said, REACH compliance testing is not always mandatory. Yet, the authorities perform checks to control whether products sold in the EU are REACH compliant. This is also why we always recommend EU importers to get their products lab tested.
The same thing goes for importers selling on Amazon in the EU. Amazon tends to be even stricter than the authorities when it comes to checking that products are compliant, and may request test reports without any prior warning. It’s better to be safe than sorry.
Compliance & Risks Interview
Does the REACH regulation really apply to every single product sold in the European Union?
Yes. Unlike EU RoHS (Restriction of Hazardous Substances) which only applies to electronic products, REACH applies to chemicals in any kind of product, known under REACH as “articles”. However, there are some exemptions for chemicals used in products for defense, medical or veterinary products, and foods, for example.
Are importers required to ensure REACH compliance on top of product specific directives?
Yes. Many obligations under REACH are concerned with giving information on chemical manufacture, import and use. REACH works on the principle of “no data, no market”. So no compliance means no product sales.
Overlap between REACH and other product directives including the RoHS, Batteries and Toys Directives, is recognized in the REACH Regulation itself and has been the subject of studies for the EU Commission, but no solution to the potential double regulation has been proposed yet.
Are any products exempt from the REACH Regulation?
The only general exemption in REACH relates to substances, mixtures or articles for national defense. These exemptions must be enacted by individual EU member states. There are exemptions from some parts of REACH for the following types of products:
Medicinal products for human or veterinary use
Medical devices which are invasive or used in direct physical contact with the body
The REACH authority, ECHA, has published guidance which gives more explanations and background information on the different exemptions and clarification on when an exemption could be applied and when not.
If a European company buys products from a Chinese manufacturer, is the EU buyer still responsible to ensure REACH compliance?
Yes. If the European company is importing the products in order to resell them on the EU market, he needs to ensure that the product complies with REACH substance restrictions if any of the entries in Annex XVII apply, and also check whether there are any Substances of Very High Concern (SVHC) in the products, as this can give rise to obligations to provide information.
Importers of certain chemicals are required to register with the European Chemicals Agency. Is registration also mandatory for companies importing finished goods?
The goods themselves do not need to be registered, but in certain circumstances, the importer could be required to register substances in the goods if not already registered. The substances would need to be registered if any of the following conditions apply:
The substance/s have not already been registered,
The substance/s are being imported in quantities over 1 tonne per year (in substance weight, not unit weight),
are intended to be released under normal or reasonably foreseeable conditions of use, and
are not listed in Annexes IV or V which provide exemptions from the registration requirement.
For more information, the ECHA has issued guidance on requirements for substances in articles for more details.
Is third party REACH compliance testing mandatory?
There are no formal requirements for third party testing; it is up to each company to judge the appropriateness of methods and laboratories.
REACH compliance testing is also a bit more complicated than simply testing a product sample. Many products contain many different components and materials. Do importers need to have all materials and components tested for compliance?
As part of the registration process, chemical suppliers have a duty to investigate the environmental and health and safety aspects of the chemical substance through a comprehensive program of data collection, testing and assessment, and to provide safety information down the supply chain so that the risks arising from the use of the chemical substances can be managed properly.
Importers can request this information from suppliers and base their REACH compliance strategy on this shared information. REACH makes explicit reference to the avoidance of duplication of testing. It is not intended that every actor in the supply chain performs his own testing.
Note: The mentioned information sharing regulations only apply to European chemical suppliers. Never take for granted that your Chinese manufacturer can obtain compliance documents from their subcontractors. In most cases, a third party lab test is the only way to ensure whether a product is REACH compliant.
What about internal components and materials that are not in contact with human tissue, shall these also be REACH compliance tested?
All parts of the products are covered by REACH, though whether users of the product come into contact with components may be relevant when assessing the risk posed by substances contained in such components.
The REACH regulation applies to substances used in products. Thus, laboratories must determine which restricted substances a certain product is likely to contain. How do you go about to determine which regulated substances should be checked?
Laboratories may help to assess what substances are contained in manufacturers, or importers, products and in what concentration level, to check their classification and assess if they are meeting the criteria of SVHC. However, the ECHA strongly advises producers, importers, and suppliers of articles to consider obtaining the necessary information by proactive requests in the supply chain.
ECHA guidance contains practical suggestions for limiting the scope of information requests, such as targeting and aiming to exclude the presence of certain substances (e.g. those on the Candidate List for authorization) instead of asking for the exact composition of articles or mixtures, which is more often confidential information.
In case the supply chain communication is not successful, other means of obtaining information on substances in articles may be used, including publicly available information sources.
What can happen to a company importing non-compliant items?
With regard to the principle of article 5, “No data, no market”, non-compliant products with the REACH regulation cannot be legally placed into the EU/EEA market. Penalties are set by individual EU member states, but can include heavy fines.
How is the European Union currently enforcing and checking REACH compliance?
Each EU Member State designates authorities responsible for the enforcement of the REACH provisions and determines on a national basis the penalties that would apply to the infringement of REACH. The penalties must be “effective, proportionate and dissuasive”.
Most countries provide for fines between 50 000 and 1 000 000 Euros maximum for the first infringement (including for legal persons). A few countries have adopted lower fines, while a few others have adopted much higher fines (55,000,000 Euros at the Federal level in Belgium and unlimited fines in the UK).
At European level, enforcement is coordinated by the European Chemical Agency (ECHA) via the Forum for Exchange of Information on Enforcement, where Member States coordinate their enforcement policies.
Do you think enforcement will become more strict in the future?
Yes. A recent report by the Enforcement Forum found high levels of non-compliance with registration requirements by “Only Representatives” (third parties appointed by non-EU companies to perform REACH obligations), importers, and companies outside the chemicals industry. Enforcement in the early stages of REACH has commonly focused on “soft” approaches including providing information and advice for complying, but the ECHA notes that it is becoming more important to employ intensified sanctions, including fines and criminal complaints, to deter persistent non-compliance.
Other directives, such as EN71, also cover labeling requirements. Are there any REACH labeling requirements applicable to consumer products?
REACH does not require any particular marking or labeling on products.
About Compliance & Risks
Compliance & Risks help companies manage compliance requirements throughout the world via our knowledge management system, C2P, daily alerts, market access and other solutions, enabling them to mitigate risk and focus on growth opportunities.
How do I assess which SVHCs my product should be tested for?
You rarely need to make this assessment on your own. Instead, I recommend that you ask an accredited lab testing company, such as SGS or Asiainspection.com, to make this assessment for you.
This is also what makes REACH so easy to deal with for importers. Rather than trying to keep up with hundreds of restricted substances, you only need to ensure compliance with the REACH regulation. In other countries and markets, things are not as simple.
Most Chinese suppliers cannot demonstrate REACH compliance
Can every single Chinese manufacturer ensure REACH compliance? Absolutely not. Most suppliers have hardly even heard of REACH. There’s only one way to determine whether a supplier is able to comply with REACH testing: ask them to provide a test report of a previous batch.
Keep in mind that a REACH test report is only valid for the specific batch that was tested. A company (i.e. a Chinese manufacturer) cannot be “REACH certified”, nor can a line of products.
In practice, this means that a previous test report is not a guarantee for compliance. Instead, it serves as a good indication that the supplier is capable of manufacturing products compliant with REACH. Yet, you cannot use an old REACH test report to demonstrate compliance for your own products.
Assessing whether Chinese factories can make REACH compliant products remains a difficult task even to this day. This is primarily due to the fact that most suppliers procure materials from a wide network of subcontractors – many of which have no chemical or heavy metals records at all.
The scary truth is that they simply don’t know what their materials contain. Or, they rather not tell you.
REACH lab testing testing
Testing a product for REACH compliance requires a high level of expertise and sophisticated laboratory equipment. Most importers and their Chinese suppliers possess neither. Therefore third-party lab testing is the only way to find out if your products are REACH compliant.
If REACH testing is critical, then a product or material sample shall be sent to a lab for testing, prior to the shipment. These international labs have offices in China and do REACH compliance testing:
As with all product testing, a successful REACH compliance test is not to be taken for granted when importing from China. Therefore the balance payment shall be withheld until the test report is delivered.
What can I do with a test report?
A REACH test report lists all chemicals and heavy metals included in the test, and whether any of them were detected. Hopefully, all you’ll see is ‘ND’, meaning that the substance was not detected. This is a sample test report:
The test report can be used to demonstrate that your products are verified as REACH compliant, in case of market surveillance authorities or Amazon would request such proof at some point in the future.
When REACH compliance lab testing fails
The outcome of a lab test can sometimes be rather unpredictable. I learned this lesson the hard way back in 2012. We managed an order of PVC plastics for an EU customer. The PVC plastics were intended to be used for toys. PVC plastics contain several hazardous substances and therefore REACH compliance is critical.
We did it by the book. We informed the supplier that we required this batch of PVC plastics to be REACH compliant (PVC can be manufactured in compliance with various standards, among them, REACH) and ordered them to start production.
Three weeks later, I arrived in Hong Kong after a trip to Europe. About the same time as I got my passport stamped, one colleague in Shanghai called me up and told me that SGS delivered the test report the same morning.
That test report ruined what would otherwise have been a nice late summer day in Hong Kong. The testing failed. One chemical, out of more than the 100 that were tested, exceeded the limit by a narrow 1.5%.
The batch didn’t pass the test.
Thus, it was not REACH compliant and using it for toys would’ve been illegal.
What made things slightly worse was that the products were already on the ocean. The cargo was loaded only a day or two before the lab test was completed. While this is plain stupid, the client placed the order far too late and simply ‘couldn’t wait’ for the lab test to come through.
In most cases, the importer would have paid the supplier in full by the time the cargo is loaded. That fact that the balance payment was not paid up saved both us and the client. Besides, the sales agreement already included terms on how to handle such a situation.
In the end, the supplier agreed to remake the batch.
This supplier is a reputable PVC manufacturer in China.
They have a record of flawless REACH, 3GP and 6GP compliance. Later on, they tracked the issue down to an uncleaned component in one of the machines. The plastics were “contaminated” by a machine lubricant during production.
There is no way to “remake” or “repair” a product that is not REACH compliant. If non-compliance is discovered after the cargo has departed from China, you’ll likely lose your entire investment.
Do you need help to ensure compliance with all mandatory safety standards?
We know how hard it can be to get a grip on product safety standards, labeling, documents, and lab testing. To help startups get a grip on the process, and avoid crippling fines and forced product recalls – we created the Starter Package:
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In addition, you can also book quality inspections, lab testing, and shipping directly from the platform. Click here to learn more.
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Co-founder of Asiaimportal (HK) Limited and based in Hong Kong. He has been quoted in and contributed to Bloomberg, SCMP, Alibaba Insights, Globalsources.com, China Chief Executive, Quartz Magazine and more.
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