There is not much time left before the first deadline for the notification obligation for PCN. Starting in 2021, many products which were previously excluded from national transitional solutions will be notified using the new notification format. In this article, I will provide a compact summary of the items that require notification via PCN and those that do not.
Basics of the notification obligation for PCN
The notification obligation is based on the CLP Regulation, Article 45. This affects all mixtures which are classified as hazardous to health (H3XX) or classified due to physical effects (H2XX). In accordance with Article 45, importers and subsequent users have a notification obligation.
Exceptions to the notification obligation for PCN in accordance with the CLP Regulation
Based on the information from Article 45 and the new Annex VIII of the CLP Regulation, which deals with the detailed specifications for European communication, additional exceptions can be derived from the notification obligation. Classification-based: Hazardous substances which only pose environmental hazards do not have to be notified. This affects all hazardous substances which only have hazard warnings with H4XX, that is to say aquatic toxicity and ozone-depleting effects. This exemption also covers hazardous substances which are only classified in one or several of the following hazard categories:
- Gases under pressure
- Explosives / mixtures containing explosives (unstable explosives and divisions 1.1 to 1.6)
Usage-based: In accordance with Annex VIII, Part A, 2.2, mixtures for scientific research and development and mixtures for product and process-oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006 are excluded. Role-based: The notification obligation primarily applies to downstream users and importers, but not to distributors. However, under certain circumstances, it can be beneficial for distributors to create notifications. Whenever a distributor is also an importer / downstream user for the product mixture under consideration, the notification obligation applies once again. Definition-based: Perhaps somewhat hidden, but still apparent in the legal text: only mixtures are notified, not pure substances. Pure substances here are defined in accordance with REACH/CLP. This does not mean that pure substances do not result in their own obligations, for example the registration obligation in accordance with the REACH Regulation.
Exceptions because the product is not covered by the CLP Regulation
With all the news about UFI, EuPCS and PCN, it should not be forgotten that certain mixtures do not fall under the regulations of the CLP Regulation at all. If the CLP Regulation does not apply to a certain type of mixtures, this is generally because these mixtures are regulated by another regulation. I found an excellent summary of possible exceptions on these grounds on the website of the German REACH-CLP biocide help desk:
- Radioactive mixtures in accordance with Directive 96/29/Euratom
- Mixtures for which the dangerous goods law applies exclusively (no placement on the market in accordance with REACH/CLP).
- Waste in accordance with Directive 2008/98/EC
- Medicinal products for human use in accordance with Directive 2001/83/EC
- Veterinary medicinal products in accordance with Directive 2001/82/EC
- Cosmetic products in accordance with Regulation (EC) 1223/2009
- Medical products and devices which are used invasively or come into direct contact with the human body in accordance with Regulation (EU) 2017/745
- In-vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746
- Food / feed in accordance with Regulation (EC) No 178/2002
- Food additives within the scope of application in accordance with Directive 89/107/EEC
- Flavourings for use in foodstuffs in accordance with the scope of application of Directive 88/388/EEC and Directive 1999/217/EC
- Additives for use in animal nutrition within the scope of application of Regulation (EC) No 1831/2003
- Animal feed within the scope of application of Directive 82/471/EEC
It is important to know which of your own products require notification. It is even possible that a product which is sold for different end uses may have to be notified for specific applications only and may be subject to different obligations under different applications. Sources: Regulation (EC) No 1272/2008 (CLP Regulation), consolidated version, status 01/05/2020 Regulation (EU) 2017/542: Annex VIII of the CLP Regulation (harmonised information relating to emergency health response and preventative measures), status 23/03/2017 website of the REACH-CLP biocide help desk