REACH Export Company Q&A
Time:2020-03-04
Views:1043
REACH is an EU regulation that restricts chemicals, heavy metals and contaminants in all consumer goods. Products containing excessive restricted substances (e. g. lead or AZO dyes) are exported in the market and import and sale are illegal.
In this article, I will explain how to determine whether a product requires REACH testing, and what steps must be taken to properly ensure compliance.
Content overview
What is the REACH?
How to evaluate which chemicals and heavy metals should my product be tested?
Compliance & risks interview
What is the REACH?
REACH (Registration, Evaluation, Authorisation, and restriction of Chemicals) is an EU regulation involving the production, import and sale of chemicals or finished products containing chemicals.
As an importer of EU countries, this means your responsibility to ensure that your products meet the requirements. The responsibility will never shift to your Chinese supplier.
The purpose of REACH is to limit human and environmental exposure to certain chemicals (especially those that are considered highly toxic). Although many products are allowed to contain certain chemicals, the quantity does not exceed the upper limit. Currently, REACH limits the use of over 1,000 chemicals.
Before REACH, there were five different chemical directives in Europe. Now they are all covered by a single standard. This can certainly ensure compliance more easily.
Which products must meet the REACH standards?
REACH limits chemicals, heavy metals and contaminants in all consumer goods sold in the EU. REACH therefore applies to the following product categories:
Clothing and textiles
Watches and accessories
Home and furniture
kitchen ware
electronic product
pack
REACH sets substance restrictions and bans the so-called Substances of high concern (SVHC). Subare are added to the SVHC list each year.
Products containing excess of certain substances do not meet REACH standards and therefore should not be imported and sold within the EU.
That is, the REACH compliance test is not always mandatory. However, the authorities conduct inspections to control whether the products sold in the EU meet the REACH standards. This is why we always advise EU importers to conduct laboratory tests on their products.
The same is true for importers selling on Amazon in the European Union. Amazon is often more stringent than the authorities when checking for product compliance, and may request test reports without any prior warning.
REACH laboratory Test
Testing of products that meet REACH standards requires a high level of expertise and advanced laboratory equipment. Most importers and their Chinese suppliers do not have one. Therefore, third-party laboratory testing is the only way to see if your product meets the REACH criteria.
If REACH testing is critical, then product or material samples should be sent to the laboratory for testing prior to shipment. These international laboratories have offices in China and conduct REACH compliance testing:
DeepLight Technology
If REACH testing is critical, then product or material samples should be sent to the laboratory for testing prior to shipment. These international laboratories have offices in China and conduct REACH compliance testing:
DeepLight Technology
As with all product testing, a successful REACH compliance testing should not be taken for granted when imported from China. REACH should be detailed before delivering the test report.
How to evaluate which chemicals and heavy metals should my product be tested?
You rarely need to evaluate it yourself. Instead, I recommend that you have a certified laboratory testing company (such as SGS or QIMA.com) perform this evaluation for you.
This is what makes REACH easy for importers to handle. You only need to make sure that you comply with REACH regulations, rather than trying to avoid hundreds of restricted substances. In other countries and markets, things are not that simple.
Does the REACH regulation really apply to every product sold in the EU?
yes. Unlike the EU ROHS (hazardous substance limits), which only applies to electronic products, REACH applies to chemicals in any type of product called "item" in REACH. However, there are some exemptions for defense, medical or veterinary products as well as chemicals used in food.
Do importers need to ensure REACH compliance on the basis of product-specific instructions?
yes. Many of the obligations under REACH involve the provision of information on the manufacture, import and use of chemicals. REACH‘s working principle is "no data, no market". So no compliance means no product sales.
The overlap between REACH and other product directives, including RoHS, battery and toy directives, is recognized in REACH regulations and has been the subject of research by the European Commission, but no potential dual regulatory solutions have been proposed.
Are any products exempt from the REACH regulations?
The only general exemption in REACH involves substances, mixtures or articles used for defense. These exemptions must be issued by the EU member states. Some parts of the REACH have exemptions for the following types of product.
Pharmaceutical cosmetics used for human or veterinary purposes
Invasive or used for direct physical contact with the body
The REACH authority ECHA has issued guidelines to provide more explanation and background information on different exemptions and to clarify when exemptions can apply.
If a European company buys from a Chinese manufacturer, does the EU buyer still have the responsibility to ensure REACH compliance?
yes. If the European company imports products for resale in the EU market, if any entry in Annex XVII applies, he needs to ensure that the product complies with the REACH material limit and checks for any substance of very high concern (SVHC), because the buyer is responsible to provide information.
Importers of certain chemicals must be registered with the European Chemicals Agency. Must companies that import finished products also register?
The goods itself does not require registration, but in some cases the importer may need to register the substance in the goods if not registered. Registration of these substances is required if any of the following conditions are met:
1. The substance has not yet been registered,
2. Import of substances exceeds 1 ton per year (material weight, rather than unit weight),
3. To release the use under normal or reasonably foreseeable conditions of use
4. Not listed in Attachment IV or V, which provides an exemption from registration requirements.
For details, the ECHA has issued guidelines on material requirements in items for more detailed information.
Is third-party REACH compliance testing mandatory?
No formal requirement; each company determines whether to do an experiment.
REACH compliance testing is also somewhat more complicated than simply testing product samples.
Many products contain many different components and materials. Does the importer require compliance testing for all materials and components?
As part of the registration process, the chemical supplier has the responsibility to investigate the environmental and health and safety aspects of chemicals through comprehensive data collection, testing and assessment procedures and to provide safety information in the supply chain to ensure that risk use of chemicals can be properly managed.
Importers can request this information from suppliers and formulate their REACH compliance strategies based on this shared information. Although REACH explicitly mentions that repetitive testing can be avoided, every participant in the supply chain can test again.
Note: the above information sharing regulations apply only to European chemical suppliers. Never take it for granted that your Chinese manufacturer can get compliance documents from its subcontractors. In most cases, third-party laboratory testing is the only way to ensure that the product conforms to REACH.
Should internal components and materials that do not contact human tissue also pass REACH compliance testing?
REACH covers all parts of the product despite whether users of the product contact human tissue
There is another protocol test to assessing the risk of substances contained in such components.
The REACH regulations apply to the substances used in the product. Therefore, the laboratory must determine which limiting substances a certain product may contain. How do you identify which controlled substances to check for?
The laboratory can help assess the manufacturer or importer, the substances contained in the product, and the concentration levels to check their classification and assess their compliance with SVHC standards. However, the ECHA strongly advises manufacturers, importers and goods suppliers to consider obtaining the necessary information through proactive requests in the supply chain.
The ECHA guidelines contain practical advice to limit the scope of requests for information, such as positioning and aimed at excluding the existence of certain substances (such as those on candidate lists for authorization), rather than requiring the exact composition of items or mixtures, which is more often confidential information.
The ECHA guidelines contain practical advice to limit the scope of requests for information, such as positioning and aimed at excluding the existence of certain substances (such as those on candidate lists for authorization), rather than requiring the exact composition of items or mixtures, which is more often confidential information.
In cases of unsuccessful supply chain communications, other means of obtaining material information in an item may be used, including publicly available information sources.
What happens to a company that imports non-compliant products?
With respect to the principle of Article 5 "No data, no market", non-compliant products conforming to REACH regulations can not be legally incorporated into the EU / EEA market. Penalties are set by EU member states, but could include huge fines.
With respect to the principle of Article 5 "No data, no market", non-compliant products conforming to REACH regulations can not be legally incorporated into the EU / EEA market. Penalties are set by EU member states, but could include huge fines.
How does the EU currently implement and check for REACH compliance?
Each EU Member State designates the agency responsible for implementing the REACH regulations and identifies nationwide penalties applicable to violating the REACH regulations. The penalty must be "effective, proportionate and dissuade".
For the first infringement (including legal persons), most countries stipulate a maximum fine of 50, 000 to 1 million euros. A few countries have adopted lower fines, while others have adopted higher fines (50 million euros at the federal level in Belgium and unlimited fines in the United Kingdom).
At the European level, the European Chemicals Agency (ECHA) coordinates enforcement through the Law Enforcement Information Exchange Forum, and member States coordinate enforcement policies.
Do you think that law enforcement will become more stringent in the future?
yes. A recent report by the Enforcement Forum found that "sole representatives" (third parties not designated by EU companies fulfill REACH obligations), importers and companies outside the chemical industry do not comply with registration requirements. REACH in the early stages of RECH typically focuses on a "soft" approach, including information and compliance advice, but ECHA said it is increasingly important to impose enhanced sanctions (including fines and criminal charges) to prevent ongoing violations.
Other directives, such as EN71, also cover the labeling requirements. Are there any REACH labeling requirements applicable for consumer goods?
REACH does not require any special marking or marking of the product.
Deeplight, with a group of strong technical experts and research team, always keep abreast of the latest developments and technical requirements of certification at home and abroad, and can design the most optimized certification scheme for your products. The above is the deep light standard for the introduction of REACH China Export Company Compliance Guide, if you have this need, please feel free to contact us for advice!
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