Do you wish to start selling detergents in Europe?
Well, Biorius, your Regulatory Expert, can also completely help you with this matter.
For your information, in order to be sold in Europe, detergents have to comply with:
- Detergents Regulation 648/2004
- CLP Regulation 1272/2008
- REACh Regulation 1907/2006
- Biocidal regulation 528/2012 (depending on the property of the product)
An EU detergent indeed depends on four regulations (and which regulations will be concerned, will depend on each detergent product) and you will find some more details about the service we offer hereunder:
In the first part of our service, we carry out 3 important matters:
1. The CLP (Classification, Labelling, Packaging) classification:
- Verification of the classification (hazard) of each of the substances present in the mixture from SDS (Safety Data Sheet) data and the substance databases
- Classification of the product (determination of the hazard)
- Determination of the mandatory pictograms on the product
- Determination of the mandatory hazard, risk and precautionary phrases for the product
- Translation in all EU language (and more) are available.
- Determination of the necessity to have a Poison Center Notification and if yes, we verify that the certificate is present or we can do the Poison Center Notification (PCN)
- Verification that none of the substances present in the product are registered on a list implying a restriction or prohibition of the substance in detergent type products
- Verification of the biodegradability information of the active substances
- Verification of the presence of phosphates (if necessary according to the type of detergent)
- Verification of the composition on the label (in addition to the CLP labeling)
In the second part (or risk assessment):
- Determine the type of risk associated to each substance
- Verify that the risk is controlled for human health for each substance. This assessment can be qualitative or quantitative depending on the case. When it is quantitative, we use the methods of the AISE (International Association for Soaps, Detergents and Maintenance Products)
Please pay attention that in the risk assessment part there is no environmental assessment because it is not required by the regulation. It is considered to be covered by the biodegradability check and classification.
It might look a bit complicated but no worries, BIORIUS can support the complete regulatory process of a detergent:
- Formula Review
- Risk Assessment
- Label & Claims Review,
- SDS (Safety Data Sheet) creation (if not available).
- The PCN (Poison Centre Notification) notification is not always necessary (and will depend on the detergent product).
- If your company is not based in the EU and/or the UK, an “Authorized Representative” for the detergent is also mandatory.
- Biorius can also become your EU and/or UK Authorized Representative.
Please pay attention that since the Brexit, an “UK Authorized Representative” (with offices in UK) became a legal obligation and completely mandatory… and of course Biorius can also become your UK Authorized Representative.
Some other important matters have also changed due to Brexit:
- Contrary to EU, Poison Center Notifications for classified products are now voluntary only for the UK and there is no obligation YET
- UFI numbers are not applicable in the UK but can be labelled anyway.
For more information or help with detergents, please do not hesitate to contact us.