Renaud welcomes our friend Fredrik Grönkvist of Compliancegate.com to discuss EU product compliance, in particular, harmful substances of note, common regulations or directives you need to comply with, and what we can learn from recent data about non-compliant products found by EU market surveillance authorities. They also provide some great advice about how to improve product chemical compliance from your suppliers during the procurement stage of your project, which is helpful for all buyers regardless of location.
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Introducing our guest: Fredrik Grönkvist of Compliancegate and our topic today.
Fredrik has been working in East and SE Asia for more than a decade, helping companies on the ground with QA work. More recently he has turned his eye to product compliance and built the platform compliancegate.com which businesses can use to more easily learn about and implement their product compliance strategies for the EU and USA.
Today we’re discussing the EU’s requirements for the chemical composition of non-food products, which chemicals have been banned, why, and more.
Overview: Why has the EU banned certain substances from being used in products?
There are a number of chemicals and substances that are toxic to the environment and to human life, for example, they are causes of cancer, reproductive damage, and other diseases, and/or they do not degrade once in the environment (including in our bodies). Some well-known examples of restricted substances are lead, BPAs, PFAs, phthalates, and more.
The EU in particular take harmful substances very seriously, and in the EU REACH directive alone there are thousands of restricted substances, and this list is continually being added to. (03:16)
Examining the list of non-compliant products caught in the EU since 2022 for chemical composition safety reasons. What can we learn?
Sofeast did some research recently to build a list of all of the products caught by the EU Commission’s market surveillance authorities and deemed non-compliant due to the presence of restricted chemicals above and beyond the allowed limits.
The information they provide explains:
- What the product is
- The country the product was detected in
- The harmful substance found and in what volume
- The country of origin (if the labelling includes it, which it should in order to be compliant)
- The outcome of the case, i.e. products were withdrawn from the market
- Explanation about why they took this action
If the EU Commission decides to take action after finding a non-compliant product, they may do the following:
- Block the product at the border
- Withdraw the product from the market
- Order a recall from end-users after the products have been sold
If a manufacturer has these products in stock they may have to either rework or destroy them.
Some examples provided:
- Gloves with a plastic part that contained too high an amount of phthalates (they are a common plasticizer that makes plastics feel softer to the touch, but are also a cause of reproductive damage and other safety issues)
- Jewelry with too much cadmium (a harmful metal that causes cancer but is often used in alloys for jewelry) (05:40)
4 directives or regulations related to the chemical makeup of products imported into the EU.
The following 4 EU directives or regulations will commonly need to be complied with by importers and many of them overlap:
- REACH – regulates numerous banned or restricted harmful substances that are not allowed to be in products above a defined level in order to improve safety. This is the key chemical compliance regulation in the EU as it applies to almost all product types.
- RoHS – regulates a short list of heavy metals and a few other substances from being used in electrical and electronic products in the EU, although it has also been adopted in China, India, and the a lot of States in the USA.
- POPs – this regulates ‘persistent organic pollutants’ which are poisonous chemical substances that break down slowly and get into food chains as a result, such as DDT, PFOAs, PFOs, and more.
- Toy safety directive – regulates harmful substances in products that children play with as this age group may be more susceptible to health issues caused by them and are, perhaps, more likely to place toys in their mouths, etc.
One doesn’t exclude another, so if you are, say, manufacturing an electronic toy, you may need to assure that the product complies with all of the above!
The most common recalls on products found in our study were for non-compliance with REACH, but in most cases, the importers were required to stop marketing and selling the products rather than the products being recalled from consumers. (10:00)
What are the key non-compliances and problem substances found for common product categories imported into the EU in the past year?
- Home textiles – REACH
- Jewelry – REACH
- Electrical household appliances – mainly RoHS, but also a good number of POPs
The non-compliances found are probably because market surveillance authorities focus on the regulation/s relevant to specific product categories, so, for example, they know that electronics are regulated by RoHS, so, for example, they may open up electronics they deem risky and check the welding for lead. If lead is found, the product likely fails RoHS compliance. They may also know that, in their area at least, they’ve been seeing problems with a specific type of product more frequently, and are therefore likely to pay them special attention.
In the past 12 months, only 14 substances led to a recall from the market. In particular, phthalates were a key harmful substance found by market surveillance authorities.
- Bags – phthalates
- Toys – 50% phthalates, 25% lead (16:02)
Are there any drawbacks to using data about harmful substances found and common non-compliances to predict future issues with your products?
Where data about particularly common harmful substances are helpful is that it gives the importer a heads-up about common risks which could be especially helpful for those who are less experienced and don’t realise that, for example, heavy metals are used in tanning for leather and can therefore sometimes be found above allowed levels in leather products if care has not been taken.
While it is good to know about common risks in your industry, it can be misleading to focus on one particular substance as compliance must be achieved on a regulation level where all substances must be considered. Therefore your supplier needs to be made aware that your product must pass, say, REACH testing and will be tested for compliance. Then they need to make sure that their material or components suppliers only provide compliant inputs to them in turn. A manufacturing agreement enforcing this and penalising the supplier for failure to comply is useful. (23:09)
What actions do importers need to take to be compliant in general?
You need to have access to the Bill Of Materials, do a risk assessment informed by what is in the BOM, and then understand what kind of regulations and directives the products falls under. You’ll then need to make it clear to suppliers that the product needs to comply with certain regulations which they should also pass on to their sub-suppliers. Assess your supplier’s ability to manufacture compliant products, what facilities and capabilities do they have? Testing equipment tends to be expensive and many suppliers won’t have it. Then you need to arrange to have the product tested per the regulation’s requirements. (27:36)
What’s the role of procurement when it comes to product compliance?
The importer buying products from abroad has a large and important role to play in obtaining compliant products. Here are a few tips for purchasers:
- Request compliance documentation from potential suppliers
Ideally, the supplier can immediately provide you with documentation proving that they are capable of providing compliant materials and products, but that’s not very likely in most cases when dealing with manufacturers in China and most other countries. At best you may receive pre-existing test reports on products that they have manufactured in the past that are, hopefully, relatively recent and issued by legitimate testing companies. Then you’ll know that they have a track record in manufacturing compliant products in the past.
- Interview the suppliers and agree on your compliance requirements
Having researched your product and now being aware of your compliance requirements you need to take this information and discuss it with the supplier. Ask them if they have had prior experience in manufacturing products that comply with these regulations. Then agree, probably using an enforceable contract, that you will only pay the balance payment for the order if the product passes lab testing for compliance with the relevant requirements. By transferring incentives to produce compliant products to the supplier in this way, you know that they will put the necessary demands on their material and component suppliers who are the next link in the supply chain.
- Make no assumptions and make your requirements clear
Even if a supplier has a good track record in compliance with your type of products or requirements, do not assume that they will produce your products to comply with those regulations unless you make it 100% clear that this is expected from them…this goes for most specifications in manufacturing. As an importer, making assumptions that the supplier will do something you need without telling them is risky when outsourcing manufacturing to suppliers in almost any country, let alone China. (29:16)
- Watch: on Youtube (The video version is a recording of the discussion and includes graphs and charts showing the data discussed)
- Don’t forget to visit Fredrik’s site Compliancegate.com and request help with your project. Their tool is great for most consumer products and will give you a detailed understanding of your potential compliance requirements.
- Learn how to create a valid manufacturing contract in China
- Find the right supplier from China. Click here to listen 👉 DIY Sourcing from China Podcast Series
- What is EU RoHS certification?
- 11 Common Electronic Product Certification And Compliance Requirements
- Get help from Sofeast with Compliance Testing Consulting where our experts confirm which standards your product must comply with and create and implement a compliance testing plan for you.
We are not lawyers. What we wrote above is based only on our understanding of legal requirements. QualityInspection.org does not present this information as a basis for you to make decisions, and we do not accept any liability if you do so.