Tag Archives: compliance

Declaration of Conformity for EU Importers: By Ferry Vermeulen

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Product compliance is much more than just laboratory testing. European importers, in virtually every industry, are obliged to issue certain documentation – to demonstrate compliance with all applicable product regulations.

Perhaps the most important of all documents is the Declaration of Conformity (DoC).

It’s a rather complex topic, so we decided to ask an expert. His name is Ferry Vermeulen, founder of INSTRKTIV.com.

In this article, Ferry explains what every EU based importer must know about drafting a Declaration of Conformity, and the various other documents you need.

Ferry, tell us a bit about yourself and Instrktiv.com

I am founder and director of business development at INSTRKTIV. After starting my own industrial design agency back in 2006, I co-founded the company Manualise in 2009.

As the CEO from 2009 – 2015, my content strategy brought the company over 15 #1 Google positions on main keywords like ‘creating user manuals’ which led to many international clients, such as Electrolux, AkzoNobel, Schneider Electric and Lid.

In 2016 I founded INSTRKTIV GmbH and moved from Amsterdam to Berlin. INSTRKTIV helps companies and brands to produce their technical documentation.

The company stands for content quality, both in the field of usability and liability: The manual as a legal document, which not only serves the keystone in terms of liability but also promotes safe and proper use, is at the core of this.

It makes me happy to help German and international companies developing appealing and compliant documentation which contribute to a better user experience.

In my ‘Man-Machine-Blog” I give hands on tips & techniques to improve the quality of content and improve the user experience. I cover topics like CE marking, the Declaration of Conformity (Read more) and Simplified Technical English. Continue Reading →

Compliance Q&A with a Watch Manufacturer: Subcontractors & Substance Regulations

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We often write about product compliance on Chinaimportal.com. However, we thought it was about time to cover a different angle: The viewpoint of the supplier. During a recent visit to Shenzhen, I had the opportunity to ask a few critical questions to a leading, unnamed, Watch manufacturer. Keep reading, and learn more about compliance and risks in Watch manufacturing – lessons that can be applied to virtually any industry.

Can you ensure compliance with REACH, RoHS, CA Prop 65 and other substance regulations?

Yes, as our main markets are the United States and the European Union, we must ensure compliance with a variety of standards and regulations. Among them are those you just mentioned: REACH, RoHS and California Proposition 65.

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Product Compliance in the LED Industry: A Case Study

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Indeed, many Chinese manufacturers claim compliance with the relevant European Union (CE Mark) and American (FCC and UL) directives and safety standards. But does this really mean that they can maintain the full set of compliance documents for all, or least part, of their products? Well, we decided to find out. In this article, we offer insider insights into the actual state of EU and US product compliance among LED manufacturers.

LED Lighting Safety Standards & Required Documentation

As explained in this article, it’s a common misconception that it’s either the manufacturer’s responsibility to ensure compliance or that the importer must only obtain a product certificate, test report or declaration of conformity. That is, however, not the case. First, as you may already be aware of, the importer is responsible for ensuring compliance – not the manufacturer. Second, as part of this responsibility, the importer must prepare all relevant documents.

In theory, the Chinese manufacturer should be able to produce these documents. Take the CE Technical File for example, which must include the following documents:

  • Declaration of Conformity
  • Test Reports
  • Circuit Drawings
  • Bill of Materials / Component List
  • Risk Analysis
  • Summary of Standards & Directives
  • Labels
  • User Guide

As mentioned, many importers make the assumption that they’re set as long as the supplier can produce a Declaration of Conformity, and the products are labelled with the CE mark. As said, this is entirely incorrect. A full set of compliance documents is mandatory. Now, how many suppliers can actually provide the full set of documents, rather than just the DoC?

Our Findings in the LED Industry

In order to not distort the result, we only picked relatively large LED manufacturers in the Pearl river delta. Some of which are established for over a decade’s experience in manufacturing LED lighting for the EU, US and other markets. Hence, we do believe that our results are representative for the industry as a whole.

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Myth and Reality of CE Marking When Importing from China

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The CE mark is a well known compliance marked, found on a wide range of different products, for example electronics, toys and machinery. The CE mark signals compliance with all, to the specific product, applicable regulations: For example the Low Voltage Directive or the EN 71 Toy Safety Directive. The CE Mark is not applicable to all products. However, it is mandatory for all products within its scope of regulations.

As I will further explain in this article, there is a lot more to CE marking than what meets the eye, namely the printed little logo. While many importers are aware that there are requirements for testing and documentation, plenty of businesses fail to understand how such documentation is produced, and what it must include.

Then there is China. CE marking procedures are not developed with importers in mind. While ensuring CE marking compliance is relatively simple for an EU or US based manufacturer, which is only concerned with its own products – it’s far more complex for importers buying from contract manufacturers in China, and other developing countries in Asia. We debunk 6 common myths concerning CE marking when importing from China, and explain the background to each one.

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CE Marking, Testing and Certification When Buying From China: Everything European Importers Must Know – By Han Zuyderwijk

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Han Zuyderwijk (LinkedIN) is the founder of Amsterdam based CEmarking.net, and one of Europe’s leading experts on CE marking and EU compliance. In this article, Han Zuyderwijk explains what CE marking is, and what kind of product documentation European importers need. He also explains why compliance with the various CE marking directives if far more complicated, when importing from China. Keep reading, and learn everything you must know about CE marking, as a European importer.

When must a product be CE marked?

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CE Marking When Importing From China: A Complete Guide

Suggestion: Watch the 10 minutes video tutorial before reading this article

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Importing from China to the European Union? Then CE marking, and compliance with at least one EN directive, may be mandatory. Yet, many small businesses importing from China remain unaware of how to determine whether CE marking is required for their products, and which party is required to ensure compliance.

In this article, we explain the basics of CE marking, including documentation, labeling requirements, regulated products and relevant EN / EC directives. What’s more, we also explain why companies importing from China, and other Asian countries, must never assume that their manufacturer is able to ensure compliance with EU standards and regulations. Continue Reading →

Product Compliance Strategies in Asia: Comparing 4 Different Industries

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Most manufacturers in China, and other developing Asian countries, are unable to ensure compliance with overseas product safety standards and substance regulations. As such, a supplier’s ‘compliance track record’ (i.e., previously issued certificate and test reports, held by the supplier) is a key signal when selecting a manufacturing partner.

However, in many industries, very few suppliers can provide said documentation, therefore leaving foreign buyers with little information to judge a supplier’s technical capability and expertise. In other industries, the number of suppliers with extensive compliance track records is larger – but still requiring buyers to apply comprehensive testing strategies. In this article, we explain how you can assess manufacturer capabilities and manage compliance strategies in four different industries; Apparel & Textiles, Watches & Jewelry, Electronics and Toys & Children’s Products.

Apparel & Textiles

Importers generally only deal with the apparel manufacturer, on the surface of the supply chain. The apparel manufacturer in turn purchases fabrics and components (i.e., buttons and zippers) from subcontractors. Nothing unusual here. However, most apparel manufacturers are unable to produce any compliance documents whatsoever. Our conclusion is that most test reports are held by buyers, and fabrics suppliers. That said, don’t expect the apparel manufacturer to share information about either their subcontractors, or customers. As a result, the buyer is, as usual, left guessing. The truth is, that many (especially small) apparel manufacturers don’t know if their fabrics suppliers are able to provide compliant produce. Continue Reading →

Electronics Regulations & Standards: Ensuring Compliance in China

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Most countries and markets, including the United States, the European Union, Canada and Australia, sets strict requirements for the performance and safety of electronics products. This should not come as a surprise, but the complexities of ensuring compliance with overseas electronics regulations and standards, in China, is not as obvious. In this article, we explain how you can avoid compliance issues and forced recalls in three, well, not so simple steps.

Step 1: Confirm Applicable Electronics Standards and Regulations in Your Market

While some standards or directives may apply to all types of electronics, others may apply specifically to certain devices and functions, for example WiFi and Bluetooth enabled products. The table below contains a brief summary of standards and regulations in the United States, the European Union and Australia: Continue Reading →

Product Testing Costs When Buying from Asia – A Complete Guide

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Today, one or more safety standards and substance regulations apply to most consumer products imported to the European Union, United States, Australia and other markets. As compliance is rather exception than rule among Chinese manufacturers, third party compliance testing is often the only way to be sure that you are not importing non-compliant, thus illegal, goods. In this article, we guide you through the different types of compliance test and their each respective cost structure. We also explain what you can do to reduce said costs.

Fabrics and material testing (REACH, California Proposition 65 and FHSA)

Substance regulations, such as REACH in the European Union and California Proposition 65, restricts substances in some, or all consumer goods. Such substances often include lead, cadmium, formaldehyde and phthalates. While batch testing is not always mandatory, compliance is. Therefore, an importer may choose to which extent its products shall be tested. Testing companies set the cost based on the number of substances (as requested by a certain regulation or standard) and the number of materials or variations, of said material. The following may count as a variation: Continue Reading →

Apparel Regulations: Ensuring Compliance When Buying from Asia

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In this guide, we share our experience sourcing compliant apparel and textiles manufacturers for American and European businesses. Keep reading, and learn more about the signals that really matter when qualifying a supplier, and why manufacturers tend to lack confidence in their own capability to ensure compliance with overseas substance regulations. Further down this post, you also find an overview of various substance labeling regulations, applicable to textiles and apparel in the US and EU.

Assessing a supplier’s ability to ensure compliance with foreign substance regulations

Apparel and textiles manufacturers with a strong compliance track record is rare. We have encountered situations where large manufacturers, even those with the US and EU and their primary markets, are unable to present a single test report proving compliance with overseas substance regulations. Our experience tells us that there are essentially three factors that matter when assessing whether an apparel manufacturer is even able to comply: Continue Reading →