I wrote about the major change to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (“CLP regulation here.
Today, we will look at the change in duty holders for submitting PCN. Let’s first look the reasoning behind the change as explained in the regulation:
“Pursuant to Article 45(1) of Regulation (EC) No 1272/2008, appointed bodies in the Member States are to receive relevant information relating to emergency health response submitted by importers and downstream users placing on the market mixtures that are hazardous based on their health or physical effects. Distributors are not required to submit such information. In certain cases of distribution across borders from one Member State to another, or where distributors rebrand or relabel mixtures, the absence of such a submission obligation causes information loss for the appointed bodies which may prevent them from providing an adequate emergency health response. To address that situation, an obligation to submit information relating to emergency health response should also be introduced for distributors, where they further distribute hazardous mixtures in other Member States or where they rebrand or relabel hazardous mixtures.”
I believe this reasoning speaks for itself – the CLP now takes into account also these situations of rebranding and selling on marketplaces in which the PCN was not submitted by the current duty holders. And the aim is clear – to enable the appointed bodies to have such information available when needed in case of poisoning cases.
Therefore a following paragraph was inserted into article 45 regarding distributors obligations:
“Distributors placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they subsequently distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers and downstream users.”
Meaning – you must submit PCN as a distributor if you place on the market to other marketplaces, where the PCN was not yet submitted or if you rebrand or relabel the mixtures (this for instance includes new trade names or even new UFI codes) for all relevant marketplaces.
However, if you can for instance agree with your supplier that they include your trade names, UFIs and all the relevant marketplaces in their PCN – then you do not have this obligation. But you do need to have proof of that.
So, in this case asking your supplier for relevant data from the ECHA Submission Portal like PCN numbers, trade names, UFI codes and marketplaces (this can be exported in form of xls. file from the ECHA submission portal and getting a “screenshot” of the successful PCN submission seem like good practice. This is the only way to be sure and be able to demonstrate to the inspection, that you have fulfilled your obligations.
This change is also reflected in the change of Annex VIII of CLP, where the duty holders and compliance dates are specified - now distributors are specifically mentioned in the legal text of CLP.
When do these obligations for distributors take effect?
The regulation says these obligations apply from 1. January 2027.
Yet in any case, even according to the current version of the CLP – the distributer must make sure that these mixtures are compliant with CLP - they can be placed on the market only if compliant with CLP.
This is specified in “Article 4 (10): Substances and mixtures shall not be placed on the market unless they comply with this Regulation.”
So my advice to distributors is as already mentioned before:
You must submit PCN as a distributor if you place on the market to other marketplaces, where the PCN was not yet submitted or if you rebrand or relabel the mixtures (this for instance includes new trade names or even new UFI codes) for all relevant marketplaces.
You can also agree with your supplier that they include your trade names, UFIs and all the relevant marketplaces in their PCN. Also, get the confirmation from your supplier that they have done this.
So basically, this is more of a “cosmetic” change, since it is now clearly specified that distributers will be also duty holders, and not only indirectly through the other article of CLP.
What is most important is that the appointed bodies have the information available on all relevant mixtures that are placed on the market – all trade names, all UFIs and in all the marketplaces they are placed on the market.
You are welcome to follow our blog here for more information to come on other specific CLP changes in the next days.
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