How To Manage Chemical Compliance: 8 Tips for Importers

We regularly provide advice to our clients so they know how to keep their products compliant. Recently the topic of restricted chemical substances came up a few times, and I thought I should put together all my general advice in one article.

This is valuable if you sell into the EU and you need to comply with REACH, POP, RoHS, food contact material regulations, the toy safety regulation, etc., if you sell into the USA and you need to pay attention to state (California Prop 65, RoHS) and federal (CPSIA) laws, and so on. It’s also good for selling into other countries have their own requirements, such as China or Japan. And to keep retailers and end users happy, too.

Here are my general tips to manage the chemical compliance of your products and keep your risks to an acceptable level.

1. Re-use components across products

When designing new products, try to re-use the same materials & components and try to avoid working with new, untested suppliers. Otherwise, if you work on many different products, you may have a very hard time ensuring the main requirements are met consistently.

Working with a few key suppliers who are collaborative and open is a great win. Designing the same components into many products is also very helpful.

At the very least, try to use the same packaging materials coming from the same packaging supplier. (This will help, also, in complying with the EU’s upcoming regulations about packaging & packaging waste and about deforestation). It’s probably a low-hanging fruit and a good first step in this direction.

2. Keep track of applicable requirements

What regulations & standards apply to your products, in the different countries/areas you sell into?

If you sell into the USA, should you pay attention to the different state laws? If you sell into the EU, do you know that food contact materials must follow different rules in different countries? Do you understand what chapters/annexes of REACH may lead to your products not being allowed in the EU? These are just a few examples.

That’s a deep topic, but you need to invest the time and/or get expert advice. You can do a lot of the research yourself online for free (tip: beware of consultants’ articles, as they may be outdated and inaccurate), but it is very time intensive.

There are solutions out there, such as Compliance Gate, for speeding up initial research. Examples of noncompliant products that were caught can be found online, for example on the RAPEX system (for the EU). And there are plenty of consultants who will be happy to help you define a risk assessment and a testing plan, but you also need to understand this topic and manage it actively.

Note: if you sell to retailers, they may have their own requirements. This is important for e-commerce sellers as well — for instance, Amazon has been asking for more and more evidence of product compliance.

3. Communicate with your suppliers

You can’t expect all your suppliers, especially small companies in low-cost countries, to guess what the requirements are for your products.

You need to tell them from the start what regulations/standards the product will have to comply with. You need to test their understanding, and ask if their existing products already comply. For example, if they say they sell to customers in the EU, ask for an example of declaration they did to one of their customers about REACH ‘SVHC’ substances — that would go a long way to show they are not entirely ignorant.

Once you communicate about this, you might notice that some of your suppliers start suggesting different materials to you. Some Chinese suppliers know that some of their products won’t pass certain tests, and hopefully they tell you right away.

Some other suppliers need to be educated about the substances that are most likely to be part of some components of the product and must be avoided. Hopefully they care about your business and they will make efforts to adapt to your needs.

4. Build the requirements into your product specifications

You need to specify in written form that all components (including packaging) must be free of restricted chemicals, or to be notified (and have the right to refuse) if a component includes a restricted chemical, depending on what exact requirements you are subjected to.

Your suppliers should commit in writing to sell products that can be sold in your market(s), and they should take responsibility for all costs incurred should that be found not to be true. That’s the very basics, and I’d say it’s not enough.

Your suppliers should also work closely with you to buy certain high-risk components from reputable suppliers and/or to provide appropriate test reports and other documents as necessary. All this will inform your risk assessment (see point 6).

5. Systematically request basic documentation (BOM, SDS…)

The most basic document, from a chemical management, is probably the bill of materials (BOM).

If the component suppliers are left blank in the BOM, or if your supplier writes their own name as the supplier of all the components, those are not good signs. You are not getting the level of detail you need.

For the high-risk materials such as paints and coatings in general, glues, oils, batteries, dangerous goods in general, and so on, having transparency into the supply chain is important, but getting a safety data sheet (SDS) is even more critical. If your sub-supplier can’t produce an SDS, you may have to work with a consultant or use a SDS authoring software.

In some cases, a formulation test report may be what you need.

If you work on many products from many suppliers at the same time, emails and shared drive folders won’t work well. You will need specialized software such as our own, SynControl, to automate a lot of the requests & ongoing maintenance of the information.

6. Assess risks based on the information you collected

You should be able to assess the level of risk for each of your products based on these elements, among other factors:

The materials that make up your products
The risk associated with the material suppliers (do they have a credible system in place and to what extent can you rely on them?)
The end use of the products (e.g. for children, or in contact with the skin)
Applicable regulations (e.g. have you already been targeted by an NGO in California?)
The distribution channel(s) and their own requirements

Ideally, your risk analysis will also look at all the components and asks ‘can this change over time and lead to the appearance of a restricted substance?’ — for example, a glue that contains acetaldehyde can transform into some formaldehyde under the effect of heat. This gets technical quickly, so you need to involve the right people to cover those types of risks, at least on your core products.

7. Should you only take into account the safety of your products’ users?

Some regulations only try to protect end users. However, if you sell globally, make sure you go beyond just caring about the end user, as you may be requested to take other considerations into account.

Ideally, you plan for the full lifecycle of each product and you study the implications of some hazardous chemicals, including these topics:

Exposure of production workers (e.g. to heavy metals, dangerous VOCs)
Use and release of harmful chemicals (e.g. pigments, finishing oils) to water/air/soil during production
Exposure of recycling operators
Ability to recycle the product into another product that will be safe of hazardous chemicals (note, this is about sustainability as much as people’s safety)

This requires communicating with the suppliers and getting visibility over the supply chain (subcontractors, chemical suppliers…), asking for information about all substances, design & material changes when needed, and some ongoing monitoring.

(This is the object of the Manufacturing Restricted Substance List approach — the way it is applied in the textile industry is described here.)

8. Gather data by testing products & materials at the right points in the supply chain

If you run Google searches, you will find a lot of advice along the lines of “beware of suppliers preparing ‘special’ samples just for passing tests”, “use only ISO 17025 accredited labs” and so forth. And there is value in such general advice, but you will need to do what is right in your situation.

If you only rely on independent lab testing and you test all your products both pre-production and in every production batch, will your economic model work??

In some cases, collecting data by testing with your factory’s equipment is perfectly acceptable. More and more electrical product suppliers have an XRF gun for an initial heavy metals verification, for instance. And that already helps reduce risks related to REACH, CA Prop 65, and RoHS. I am not aware of any requirement to use an accredited lab for those tests.

On the other hand, some regulatory bodies will be picky and accept only certain labs — not just any ISO 17025 accredited testing house. See the CPSC (for children products sold in the USA) as an example.

It’s not just about picking the right lab. You need to set up a reasonable testing plan to keep tabs on major risks without spending all your margin. That means not necessarily testing for every med/high-risk substance on every batch.

Let’s take an extreme example. If you know where the key components come from, your risks are much lower. If you know for a fact that the plastic polymer in your bottle is Tritan and there are no colouring pigments or other additives, do you need to test it for the presence of BPA? The risk is quite low. (Side note: at the factory will help a lot.)

Similarly, if the same supplier uses the same material in 2 colours across 10 different product SKUs, you may only need to check it on 2 SKUs (once per color).

That’s where your risk assessment allows you to adjust where you spend your testing budget. A well organised supplier that has a proper traceability system and is relatively transparent will tend to necessitate much less testing. Hopefully you have a feedback mechanism to your sourcing people so they accept a slightly higher product price from those good suppliers…

I hope that all makes sense. Have I forgotten some important tips? Please write in the comments below and we’ll make sure to respond and update this article.

As a final note: controlling restricted/prohibited substances is an important aspect of product regulatory compliance but it is not the only one. Your products may be subject to standards that call for physical tests, electro-magnetic tests, and so on.

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