Regulatory position

Recent regulatory developments

UPDATE - 22 May 2017 - SCCP under the Stockholm Convention

At the 2017 COP in Geneva, SCCP was listed on Annex A (elimination) with a list of specific exemptions that covers nearly all current uses. These include rubber transmission and conveyor belts, leather fat liquoring, lubricant additives, outdoor decoration bulbs, waterproof and fire retardant paints, adhesives, metal processing and secondary plasticisers (except in toys and children's products). These exemptions will now be applied for by those interested parties and the POPRC will assess the exemptions (need and availability of alternatives). Such applications must take place by 2019 and will be evaluated by POPRC in their 2020 meeting for presentation at COP10 in 2021. Such uses are often given a 5-year lifespan with a possibility of an additional 5-year extension.

Questions were again raised by several parties on whether SCCP meets the bioaccumulative and long-range transport criteria and chemical identity was also questioned. A 1% limit was placed in mixtures containing SCCPs, despite the fact that when one considers the chemistry of these substances, SCCP cannot be present in MCCP or LCCP.

UPDATE - 13 February 2017 - MCCP Substance Evaluation

Following the ECHA Board of Appeal decision, additional testing will be performed on MCCP as part of the substance evaluation in REACH. This testing (which is now underway) will evaluate the Persistance and Bioaccumulative status of specific MCCP products and use these to judge the SVHC status of them. This must be completed by 09 September 2018. The UK authorities (who are conducting the evaluation) will then have one year under CoRAP to evaluate the updated REACH dossier meaning that by September 2019, producers will receive the decision. The CASG is confident that the testing will prove that these substances are environmentally safe and remain highly beneficial to society.

MCCP is also being registered in South Korea under 'K-REACH' by 01 June 2018.

UPDATE - 11 January 2017 - SCCP under the Stockholm Convention

During another controversial POPRC (ENB), Annex F for SCCP was approved and the recommendation given to discussion at the 2017 COP in Geneva was given that SCCP be listed on Annex A - elimination without specific exemptions. Incorrect assumptions about SCCP in other chlorinated alkanes and an erroneous assessment of alternatives were also noted and were poorly addressed. Questions from several parties (signatory countries) also remain over the scientific rigour of the process and if SCCP meets the requirements for Annex E (as proposed in November 2015) but these will be discussed at the COP in late April/ early May 2017. 

UPDATE - 11 February 2016 - MCCP and LCCP REACH reviews

Following the ECHA Board of Appeal decision, additional testing will be performed on MCCP as part of the substance evaluation in REACH. This is due within the next three years. Also the LCCP REACH dossier and CSR has been marked for a compliance check and as such the applicants are being given the opportunity to update the dossiers. Both will be useful in showing the safety of these chemicals in the environment and their lack of impact on human health.  

UPDATE - 20 November 2015 - POP regulations update

Short Chain Chlorinated Paraffin (SCCP) usage has been updated as part of an update to regulation No 850/2004 on Persistant Organic Pollutants (Annex I).

The regulation states that preparations containing SCCPs lower than 1% by weight or articles containing SCCP lower than 0.15% will be allowed. Usage includes mining conveyor belts and dam sealants in use before 04 December 2015 and articles other than these in use before 10 July 2012.  

 

Overview of chlorinated alkanes in European regulations

CAs are under a high degree of regulatory scrutiny, with one of the main questions being how much can legally be in a product or material. Much of this is due to the regulatory environment surrounding SCCPs and mistakes people make when they define CAs (caused by confusion over how they are made). MCCPs and LCCPs have very different human and environmental interactions and so are not classified in the same way as SCCPs.

CAs are specifically defined under CAS on the basis of their range of chain length sizes. However, their exact composition is unknown, and so they are technically defined as UVCBs (unknown or variable compositions, complex reaction products and Biological materials). It therefore follows that, by their very nature and as the composition is unknown, when someone talks about an impurity in a UVCB (such as MCCP having SCCP impurities in) this is not actually possible (as the composition is unknown). This is a well-known situation that is accounted for under ECHA/ REACh guidance.

Further, unlike MCCP and LCCP, SCCPs are classified as SVHCs. Any Substance considered to be of Very High Concern (SVHC) pursuant to Article 57 of the REACh Regulation might be introduced onto the “Candidate List” (listed on the ECHA website). From this list, substances on which there are health and/ or environmental concerns will be prioritised for inclusion in Annex XIV of REACH. Once the European Commission has included the substance in the Annex XIV list and the designated 'sunset date' has passed, the substance cannot be placed on the market or used without the prior authorisation of the European Commission (NB. unless that use is exempt from authorisation).

The situation is more complex when the substance appears in a product or finished article. Under REACh, articles are defined as “an object which, during production is given special shape, surface or design which determines its function to a greater degree than does its chemical composition”. Examples of this include clothing, furniture, spare parts etc.

According to Article 7(2) of the REACh Regulations, producers and importers of articles have to notify ECHA if a substance, listed on the candidate list, is present in their articles above 1 tonne/year and in a concentration > 0.1% w/w. Also, if requested, any supplier of an article containing a SVHC on the candidate list, in a concentration above 0.1% (w/w), has the duty to provide the recipient of the article with sufficient information to allow safe use of the article. When requested, this information should be provided free of charge, within 45 calendar days of the request (also known as Article 33). Such information should also be provided to recipients automatically as soon as the substance has been included on the Candidate List for authorisation. Note that the term “recipients” refers to industrial or professional users and distributors, but not to consumers. If a request is made by a consumer, the same supplier of articles has to provide the safety information about the SVHC to their consumer. If no particular information is necessary to allow safe use of the article, as a minimum, the name of the substance in question has to be communicated to the consumer. More specific notes on this are can be found on the ECHA website.  

How to determine the concentration of an SVHC in an article.

A SVHC on the Candidate List may be present in different concentrations in different components of the same article, e.g. one concentration of the SVHC in the case of a laptop and another concentration in the power pack. Under the regulations, the concentration of this SVHC has to exceed 0.1% (w/w) in the entire article. In order to check for this it firstly needs to be known, for each component, whether the component contains above 0.1% (w/w) of the SVHC or not.

To illustrate the situation that may arise when checking the 0.1% threshold, the example of the laptop assembled from different components, such as transformer, motherboard, memory, processor, case, etc.can be developed further. If no component contains above 0.1% (w/w) of a SVHC on the Candidate List, then it is taken that the entire laptop does not contain above 0.1% (w/w). If one or more components contain above 0.1% (w/w) of a SVHC on the Candidate List, the producer/importer of laptops needs to calculate the entire content based on an ‘average’.

Likewise, if a producer of laptops adds an SVHC to one or more parts of the laptop, he has to follow the same approach in order to check whether the 0.1% threshold is exceeded for the laptop he finally places on the market. Guidance on how to calculate these is also present on the ECHA website.  

UPDATE: As of 10 September 2015, after a Court of Justice of the European Union ruling  - the 0.1% applies not just to assembled products but to constituent parts as well. For clarification, they also state that a separate notification is required for each article that makes up a complex product, when more than 0.1% of the weight of this article is made up of a SVHC. This obligation applies to articles made by the producer itself and not to articles made by a third party (who are bound to provide notifications). As such several notifications may thus be made for one complex product.

Particularly useful information on the current situation can be found here (German Umweltbundesamt - checked February 2017).

The short-chain grades have also been provisionally classified by the European producers as 'Dangerous for the Environment'. They are also categorised by the International Maritime Organisation (IMO) as Severe Marine Pollutants and are now placed in UN class 9 for road/rail transport in Europe.

More information about the International Maritime Organisation on imog.org.

Further, the 25th Adaptation to Technical Progress to the Dangerous Substances Directive 67/548/EEC has formally classified C10-13 chlorinated paraffins as Category 3 carcinogens (R40) and as Dangerous for the Environment (R50/53).

The EU have recognised that medium-chain chlorinated paraffins should not be classified as carcinogens.