Products » Consultancy » REACH Consultancy » REACH Guide » REACH - Polymers, Articles and Preparations

REACH - Polymers, Articles and Preparations

The REACH (EC 1907/2006 the Registration, Evaluation, Authorisation and Restriction of Chemicals) regulations adopted in July 2007 set about new obligations for anyone that makes use of chemicals within their business inside the EEA (European Economic Area). One of the key aspects of the regulations is the requirement for manufacturers (or importers for manufacturers based outside Europe) to establish dossiers of hazard information on substances sold within the EEA at greater than 1 tonne per annum, which then need to be submitted to ECHA (European Chemicals Agency) by various deadlines dependent on the tonnage sold. Failure to complete registration where required means that manufacturers and importers are banned from selling goods that contain unregistered substances in the EEA, based on what the regulations call ‘No data, no market’. However a number of substances are exempt from registration based partly on the application of the substance and sometimes the nature of the substance itself. For manufacturers and importers that make use of such exemptions it is important for them to be able to show that they understand the regulations and the exemption they want to make use of in order not to fall foul of the ‘no data, no market’ rules.

Under the REACH regulations ‘polymers’ are considered exempt from the registration process. However for polymers that contain monomeric units at greater than 2% wt/wt and where the monomer content sold is in quantities greater than 1 tonne per annum, there is a requirement to register the monomer (article 6(3)). The nature of polymers means that typically they are inert and represent a low hazard; they also comprise a wide group of substances used across the whole of Europe for multiple applications and it is for these reasons that polymers are currently exempt from registration. However please note that as a requirement of article 138(2) ECHA will be carrying out a review of the situation surrounding polymers in the coming months to assess risk and hazard of specific polymer sub-groups.

The sheer diversity and broad application of polymers means that many companies will want to make use of the polymer exemption. However the REACH regulations are specific in what is considered to be a ‘REACH polymer’, and therefore there’s a genuine need for manufacturers and importers of goods to understand the regulations and assess whether the polymer out on the shop floor is actually a REACH polymer, or whether it more accurately fits a different classification under the regulations. The current article based on the ECHA guidance is intended to help put in lay terms the different classifications and assist the reader in identifying the substance they make use of. For further information please refer to the ECHA guidance, references are given at the end of this document.

 

Figure 1

 

Polymers

The general definition of a polymer is supplied within article 3(5) of the regulations as:

“A substance consisting of molecules characterised by the sequence of one or more type of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in molecular weight are primarily attributable to differences in the number of monomer units”.

Equally a monomer is defined in article 3(6) of the regulations as:

“A substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process”.

As stated polymers are exempt from the registration process under REACH, although they can still be subject to authorisation, please see the ECHA guidance for further details. Monomers however are subject to REACH registration where they fulfil the criteria of article 6(3). Sometimes, and particularly in the case of importers, it can be difficult to gauge whether the polymer being used meets these requirements and whether a registration should be in place. The advice in this case is to promote good communication channels across the supply chain and to gather as much information as possible to make a sensible conclusion. ECHA makes use of OECD approved test methods where necessary.

The general definition of a polymer as provided by the regulations sets a good overall context to identify what is considered a polymer. However in practice things are slightly more complex and centre on the second part of the definition (in article 3(5)) relating to the weight of monomers. Beyond the generic terms, identifying a true REACH polymer is a two-step process as defined below:

Step 1- the substance must contain equal to or greater than 50% wt/wt polymer molecules* (* a molecule consisting of at least 3 co-valently bonded monomer units).

If the substance contains less than 50% wt/wt of the polymer molecules it is not considered a true REACH polymer on the basis that other substances will significantly contribute to the characteristics of the overall substance.

Step 2 – The amount of polymer molecules* presenting the same molecular weight must be less than 50 weight percent of the substance. 

What this means in practice is that at the n3 monomer level, if the overall weight of the 3 monomer units combined is greater than 50% of the overall weight of the entire substance, the monomer units are large enough in their own right that they prevent the overall substance from acting like a true polymer.

If the substance under review fails to meet the requirements of either step 1 or step 2 it is not a REACH polymer and can more likely be characterised as either an article or a preparation*, described in the next two sections. If the substance does meet these requirements then it can be considered a polymer and is exempt from REACH registration, although again care needs to be taken regarding whether the polymer is still subject to authorisation or registration of the monomer units.

Articles

The general definition of an article is supplied within article 3(3) of the regulations as:

“An object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition”.

Therefore based on this definition the shape or design of the article has to have greater bearing on its function than its overall chemistry. In some cases this can be an obvious definition, for example with a child’s plastic drinking cup, the shape of the cup is of greater relevance than the material it’s made of and therefore the item is a true article. In other cases it is less obvious. The example given in the guidance is of a wax crayon. In this case the crayon is made of paraffin wax and a pigment, its function is to apply that pigment to a piece of paper. On this basis the ‘pigment’ is more important than the shape of the wax crayon. In this case a wax crayon is not an article but a preparation*.

It is also possible for polymers to form parts of articles, and again in this case the manufacturer or importer need to carefully assess whether the shape, or design of the component is more important than the chemical composition. In this case the physical attributes of the material (such as being water proof) would not count as a shape, surface or design feature but relate to the chemical composition. If the shape and design of the component and overall article is more important than its chemical composition it can be considered an article.

Articles are also exempt from the REACH registration process. In terms of substances within articles, provided that substance cannot leach during the normal use and lifetime of the product then it does not need to be registered with ECHA. However if there is potential for substances to leach from the article, and they breach the 1 tonne threshold (based on weight of the substance within the article) then a registration dossier is required and the full details of the dossier (and potentially chemical safety report) will be based on tonnage of substance sold based on the content of the article.

If a substance under review fails to meet the requirements for either a polymer or an article then it is most likely a mixture.

Preparations*

The general definition of a preparation* is supplied within article 3(2) of the regulations as

“A mixture or solution composed of two or more substances”

It’s important to recognise the change in terminology with the advent of the CLP (Classification, Labelling and Packaging of substances) regulations, as the term ‘preparation’, became ‘mixture’ in January of 2009 to maintain continuity with CLP. The definition however still remains. In this case if the substance under review has been recognised as not being a REACH polymer or article then it is most likely a ‘preparation/mixture’. In this sense the assumed polymer becomes the ‘mixture’ and the monomer components will then be substances within the mixture. The mixture (assumed polymer) in this sense will be exempt but the substances within the mixture (the monomers) will require to be registered if sold in equal to or greater than 1 tonne per annum.

This definition is subtle but key to whether a registration is needed or not. If the substance under review is a true ‘REACH polymer’, the monomers only need to be registered if they fulfil article 6(3), which is that the free monomer makes up more than 2% wt/wt of the total and that more than 1 tonne per annum of this substance is sold per year in the EEA. In the case of a substance being classified a ‘mixture’ then the total quantity of monomer within the substance counts towards whether a registration is needed or not. This makes it more likely that the 1 tonne threshold will be reached and a registration becomes necessary.

Summary

The REACH regulations have been termed the most significant piece of chemical legislation in twenty years and place direct obligations on anyone making use of chemicals within their business. For manufacturers and importers (if the manufacturer is based outside the EEA) of chemical goods there is a need to register dossiers of information on eligible substances, which have to be submitted to ECHA. Where exemptions from registration exist it’s important that manufacturers/importers understand the regulations and the exemption they are making use of. For downstream users it’s important that they are also aware of these issues in order to maintain a secure supply chain of goods.

The issues surrounding the exemptions for polymers require some careful handling and understanding to ensure that the goods on the shop floor meet the definitions issued by ECHA. Failure to correctly identify and make use of such exemptions can result in a ‘no data, no market’ situation, which can have severe implications for the entire supply chain.

This document has been intended to help guide the reader through some of the issues that exist and help identify and classify which exemptions can be applied. The flow chart in figure 1 also presents the information from the current document in illustrative form.

Further information on these issues can be found in a range of guidance documents produced by ECHA:

http://guidance.echa.europa.eu/guidance_en.htm

Please see the following for further clarification:

i Guidance on registration – version 1.6 – January 2011

ii Guidance for monomers and polymers – Version 1.1 – May 2008

iii Guidance for substances in articles – Version 2 – April 2011