Europe
updated on 22 03 2023
Over the last two months the sciBASICS team has been learning a lot about MSDS and the question on emergency numbers to be put under section 1.4!
Now, that was a hell of an ordeal because... while the question is simple : "what kind of emergency number can/must we put on a MSDS" the answers we got from ECHA, national authorities and even private services were all but!
So, we thought we share some of these findings with you - provide you with the a nutshell summary of our findings (so far - mind you, I expect this to change ! :))
Here it is, in a nutshell:
We are no experts in REACH and CLP but from what became clear from the reading of several documents and discussion with various authorities is that:
- if your product is not classified, you don't need an MSDS. That's in theory. because, in reality, we all know that MSDS are requested very often and are part of most applications in most countries. So far, so good.
- the thing is: If you set up an MSDS, it needs to be in line with Regulation 1907/2006. Which, in turn, means, that you need to provide an emergency number.
- that emergency number can not be the general emergency line (911 in the US, 100 in Belgium, etc.) It must be a specific number. It says the number to be used must be the one from the poison centers in the different countries. Only, if you use the numbers of these poison centers, you also have to notify the poison centers that you are using their numbers. Which makes sense.
The first annoying thing is that this notification must be done either through a national procedure, or through the ECHA PCN system. This requires use and knowledge of IUCLID. Have fun! :)
The second annoying thing is that these systems are not designed for products that are not classified according to CLP.
So, what to do. Cat biting its tail - you get the picture.
So, we concluded on a solution which seems to fly. Wanna know which one? We will talk about is in our first training on Scientific Regulatory Affairs - entry level which will be taking place soon! Interested? Get in touch!
06 01 2022
It has been long awaited, the update of the European Fertiliser Regulation 2003/2003 to eventually include biostimulants !
The good news is: it now includes biostimulants. It is in force since 16 July 2022. While the new European Fertiliser Regulation is in force and applicable, national fertiliser legislation remains in place and fertilisers and biostimulants can be placed on the market under these national laws.Many Member States are currently adapting their national legislation to align with the European Fertiliser Regulation 2019/2009.
So, what does it bear, the brand-new Fertiliser Regulation 2019/2009 ?
For starters, its scope has been extended to include now products such as soil improvers, biostimulants and organo-mineral fertilisers and it replaces the 2003/2003 regulation. While its scope has been extended, the plant protection products regulation will be amended to reflect the new scope of the fertiliser regulation, whereas “biostimulants” will be defined as:
“Products stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:- nutrient use efficiency;
- tolerance to abiotic stress;
- quality traits;
- availability of confined nutrients in soil or rhizosphere.”
There we are!
In contrast to national fertilizers, an EU fertiliser product complying with the regulation should be allowed to move freely one the European internal market and EU Member States are not supposed to hinder the free movement of any compliant EU fertilizer on their market. However, “a Member States, which, on 14 July 2019 benefits from a derogation from Article 5 of Regulation (EC) 2003/2003 in relation to cadmium content in fertilisers granted in accordance with Article 114(4) TFEU may continue to apply its national limit values for cadmium content.” Any cadmium content of a fertiliser product, as well as the knowledge of national limit in contaminants is therefore critical.
The new EU fertiliser regulation 2019/1009 (hereafter called the new fertiliser regulation) has divided EU fertilisers into different product function categories (PFCs). Each category is subject to specific quality and safety requirements. Annex I contains the list of these product function categories.
Likewise, specific requirements in terms of components and other requirements have been set for biostimulants, soil improvers, and inhibitors.
Raw materials that can be used for the manufacture of fertilisers are set out in Annex II of the new Fertiliser Regulation.
Label requirements are set out in annex III of the new Fertiliser regulation 2019/2009.
One of the "hot topics" during the discussions on how to amend the Fertiliser Regulation were phosphonates. These, as specified in the new Fertiliser Regulation, "may not be intentionally added to any EU fertilisers. Unintended presence of this substance may not exceed 0,5%."
Interested in the detailed summary of the new EU Fertiliser Regulation? It should be available soon. If you don't want to miss its publication, just subscribe to the updates.
