Common Compliance & Recall Risks for EU & UK Packing MaterialsSofeast commissioned some research recently on which chemical compliance incidents occurred in EU countries in the past year 22/23, the substances found, where, and the actions taken by authorities.

Let’s look at packing materials which were found to be non-compliant by market surveillance authorities. Packaging materials could be made of plastic, card, or metal, depending on how they’re used, therefore, there is scope for all kinds of problems.

Note: we only cover chemical compliance in this article.

 

 

What are the key applicable regulations & directives?

In general, we investigated these common regulations and standards that market surveillance authorities tend to check products against:

 

Market surveillance on chemical substances: recalls and withdrawals from market

Compared to consumer goods, packing materials had relatively few chemical compliance incidents during the year 22/23 with only 5 incidents logged that we found:

packing materials total incidents
These incidents were due to the detection of the following substances:

  • Di-(2-ethylhexyl) phthalate (DEHP) (most comm, and often in plastics) x3 
  • Cadmium (likely in metal parts) x2

Phthalates are plasticizers added to plastics to increase strength, durability, flexibility, and transparency. They’re banned or restricted because they’ve been scientifically shown to disrupt hormones and cause birth defects and are banned under RoHS.

Cadmium is a toxic metal often found in metal parts and is a common by-product of zinc production. However, it’s one of the RoHS-banned substances because it is a toxic carcinogen.

 

Which regulations were not complied with and by whom?

The packing materials were mainly in breach of REACH which regulates the use of harmful chemicals in most products, but one also failed to comply with RoHS which regulates the use of certain hazardous materials in the manufacturing of electrical and electronic products.

The offending packaging was all found to come from the PRC. While that’s probably not a surprise as most of the non-compliant products in general were from there, it still serves as a warning if that’s your manufacturing base.

total incidents packing materials
What steps did the authorities take?

Once again, Scandinavia takes the mantle of being strict on products at the border. In this case, only Sweden found issues with packing materials:

  • Sweden 4x (1 RoHS & 3 REACH)

All of these non-compliant packing materials were withdrawn from the market.

 

General advice to reduce such risks

Make sure you work with suppliers who are aware of the regulations in the countries where the devices are to be sold.

Ask your supplier for confirmation that every material is compliant, with testing reports if possible as evidence.

If you have a doubt, run a risk analysis (and the list of most common issues found, as laid out above, will be useful) and take action. It could mean that you select the suppliers of certain materials directly (and you ensure those are reputable manufacturers that show evidence of compliance) and/or you run some laboratory tests.

Finally, if you are still unhappy about the product’s risk profile, you may have to re-design it and choose less risky materials.

 

What can importers of packing materials learn from this data?

First of all, this information should be of concern to most importers, because your product is likely to be packaged somehow and this may be checked by market surveillance authorities for compliance with chemical safety requirements. How many products are sold with some kind of plastic packaging today, for example? And, as we know, there is always a danger that plastics will contain banned phthalates if not other substances.

So, even if packing materials aren’t your main import, it pays to ensure that they’re not manufactured with hazardous and restricted chemicals…and, if your suppliers are Chinese, be extra vigilant and do your due diligence on the packaging before the shipment leaves the factory.

This entry was posted in Product Testing and tagged , , , . Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *