01 June 2009

“Responses to comments” document for Alkanes,C10-13,chloro (SCCPs) (EC number: 287-476-5)

This document provides ECHA’s responses to the comments received during the public consultation on the draft recommendation for inclusion of substances in Annex XIV of REACH which took place between 14 January and 14 April 2009.   

I - Comments and responses to comments on the prioritisation

 General comments on the prioritisation
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090206	Industry or trade organisation (on behalf of), Germany	Page 1: This substance will not be used since many years in the European leather and textile industry. Nevertheless, it will be used in many Non-EU-Countries as well as in some EU-Associated-Countries with the effect, that via imported semi-finished (woven fabrics, narrow fabrics...) and finished textile products (clothing, house and home textiles...) coming from these countries into the EU market our people and our environment will be polluted step by step! Therefore we propose to insist on all importers and to force them to import such kind of semi-finished and finished products only absolutely free of this substance! It cannot be and it is unacceptable that our EU producers don't use such a substance since many years and via large imports of semi-finished and finished products such a substance is coming in! 	With regard to concerns relating to the import of SVHCs via (semi-)finished articles it should be noted that the REACH Regulation contains provisions that allow to identify and, if deemed necessary, restrict such imports of SVHCs within articles:
•	importers (and producers) of articles are required to notify the presence of candidate substances (i.e. substances identified in accordance with Article 59 as meeting the criteria of Article 57) in articles when the substances are present in those articles above a concentration of 0.1% (weight/weight) and the quantity of a substance totals over 1 tonne per producer or importer per year. If such a substance is intended to be released and the same conditions regarding concentration and tonnage are met, the substance requires registration (see provisions or Article 7.1 and 7.2 of REACH),
•	if considered necessary, Community-wide measures restricting the placing on the market (including the import to the EU) of articles containing SVHC substances can be imposed. REACH Article 69.2 requests ECHA to consider whether the use in articles of a substance subjected to authorisation poses a risk to human health or the environment that is not adequately controlled. If ECHA considers that the risk is not adequately controlled, it shall prepare an Annex XV dossier addressing these risks. Further, the Member States can develop restriction proposals addressing such imports of SVHCs with articles. The European Commission can take initiative as well and request ECHA to develop restriction proposals.
	
20090309	Industry or trade organisation (on behalf of), Belgium 	The members of [the organisation] would like to apply for exemptions to the authorisation requirement for alkanes, C10-13, chloro (short-chain chlorinated paraffins or SCCPs). Members of our group have been successful in persuading users to substitute SCCPs and this is demonstrated by the decline in the EU market for SCCPs from >13,000 T in 1994 to < 850 T in 2008. Remaining users of SCCPs argue that there are no suitable alternatives. Where possible users have chosen to switch to MCCPs, however it has been found that in some safety critical applications substitution by MCCPs is not possible. For example, when SCCPs are used as fire retardants it is important to get as high a chlorine content as possible as it is the chlorine that provides the required fire retardancy. It is not possible to make MCCPs with as high a chlorine content as SCCPs as the longer chain length combined with high chlorine content would make a high chlorine MCCP product too viscous to add to some formulations. Based on data for 2004 (used in the updated Risk Assessment for SCCPs prepared under the Existing Substances Regulations), the industrial application of paints would no longer pose a risk based on the PEC/PNEC approach. The general use of SCCP as flame retardants is most critical especially in plastics, rubber, paints and sealants. These are all non-emissive uses of SCCPs. We therefore request exemptions from authorisation for the following use categories of SCCPs: industrial application on conversion/compounding of plastics and rubber industrial application of paints and coatings According to the categories outlined in RIP 3.2.2 we believe that the most relevant use categories to cover the exemptions we are requesting are the following: SECTORS OF USE SU11 – Manufacture of rubber products SU12 – Manufacture of plastic products including compounding and conversion PRODUCT CATEGORIES PC9 – Coatings and Paints, Fillers, Putties, Thinners PC32 – Polymer Preparations and Compounds DESCRIPTOR FOR SUBSTANCES WITH NO INTENDED RELEASE AC15 – Rubber products C18.1 Constructional articles and building materials for internal use C18.2 Constructional articles and building materials for outdoor use Please let me know if you require additional information to support our application for exemptions.	The Authorisation procedure does not foresee a possibility to exempt uses from the authorisation requirement on the basis of non-availability of alternatives. Uses can only be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled (Art. 58.2).
It should be stressed that in fact the lack of suitable alternatives is one of the conditions for granting an authorisation in accordance with Article 60(4) (so called socio-economic route for authorisation, which is the only possible route for substances like SCCP, which are included in Annex XIV because they have been identified as PBT or vPvB substances).

Information on lack of alternatives may be part of the applications for authorisation to be submitted to ECHA (art. 62.4 (d) – Chemical Safety Report and (e) – analysis of alternatives), and may be taken into account when the Agency needs to develop its opinions on the applications and the European Commission takes a decision on whether to grant an authorisation and what type of conditions and how long review period such an authorisation will include.
	
20090313	Company (on behalf of), Germany	Proposal: To exempt from the authorisation requirement the placing on the market of SVHC in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Justification: Defined substance samples are required to calibrate analytical instruments to identify and quantify the substance (e.g. for measurement solutions used by enforcement agencies). The applications are laboratory use by professional users (minimal risk to consumers and the environment, controlled professional use and disposal). The volumes required for calibration samples (analytical standards) are minimal, typically a solution in the range of millilitres. The concentration of the chemical standard substance is normally low - in the range of 0.1%-2% and often lower according to the sensitivity of the measuring technique. For existing or future development of new highly sensitive analytical test solutions (e.g. using mass spectroscopy, chromatography, optical spectroscopy, etc.), the use of analytical standards for calibration purposes is indispensable and is required for deployment of technical verification instruments for operational enforcement of environmental policies. A substitution of the substance of concern is technically not possible due to the calibration purpose of the usage. Comment on Terminology: Analytical standards are sometimes also named chemical standards, calibration standards or samples or test samples.	According to Art. 56(3) of the REACH Regulation, the obligations of Art. 56(1) and 56(2) “shall not apply to the use of substances in scientific research and development”.
Hence, as defined in Art. 3(23) of REACH the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year does not require authorisation.
ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use does not require an authorisation.	
20090324	MSCA, The Netherlands	In general, the background documents and justification provided by ECHA are well prepared. On one important aspect NL disagree with the proposal from ECHA: according to us the fact that a substance can easily replaced by a an other substance in same group (in the case of diarsenic trioxide and sodium dichromate), is not an argument to de-prioritize the substance, because it other wise will be very hard to take care of problematic groups of substances. According to NL prioritisation of one of the substances in the group is a signal to industry that also these kind compounds are subject to the authorisation regime. NL used a ranking system to analyse the available information on hazard properties, manufacture, uses and releases: Aspect Points 1. PBT/vPvB no 0 yes 1 2. Volume low (10000 t/yr) 5 3. Use (number of point sources, potential for worker exposure, potential for consumer exposure) small/low 1 medium 2 many/high/widespread 3 4. Release non-diffuse/controlled insignificant 1 medium 2 diffuse/uncontrolled/significant 3 Following this analysis, HBCDD, DEHP, Musk xylene, SCCP, BBP and DBP are considered to have high priority for inclusion in Annex XIV because they fulfill indisputable one or more of the prioritisation criteria in REACH article 58(3). Because the production volume, the use and consequently the potential exposure will not result in significant risks for human or environment, the following substances are not fulfilling the criteria for prioritisation: anthracene, TBTO, cobalt dichloride, diarsenic pentaoxide, lead hydrogen arsenate and triethyl arsenate. For the three remaining substances, MDA, sodium dichromate and diarsenic trioxide, there are some doubts. Finally, NL concluded that MDA and sodium dichromate should be given priority for inclusion in Annex XIV. For diarsenic trioxide NL concluded that the substance is of low priority. More details are given at substance specific comments.	The prioritisation of the 7 selected substances for ECHA’s recommendation of candidate substances to be included in Annex XIV is the result of the application of a coherent priority setting approach, which has been presented to and discussed with the MSC. Many members of the MSC expressed support to ECHA’s priority setting approach and in general it was positively received.
However, if there are elements in the prioritisation approach that are not supported, these may be discussed in forthcoming MSC meetings with the objective to further develop the approach so that it gets as broad as possible agreement.

As regards NL’s disagreement with ECHA’s stance on the pertinence of subjecting substances to authorisation that could be easily replaced by other substances with the same/similar hazard profile: NL deem prioritisation of one of the substances in a group of substances with similar hazard potential to be a sufficient signal to industry that also these other compounds of the group are subject to the authorisation regime. We believe however that this view has no legal foundation in the REACH regulation since only substances whose ID is explicitly specified in an Annex XIV entry are subject to authorisation. Hence similar substances are not subject to this requirement, unless they are listed in Annex XIV. Prerequisite for inclusion of a substance in Annex XIV is the explicit identification as candidate substance. This requires specification of its ID and properties in an Annex XV dossier and a formal identification of its SVHC properties by the procedure laid down in Article 59.
	
20090408	MSCA, Ireland	IE would like to support the work that ECHA has done in prioritising and recommending the following 7 substances for inclusion in Annex XIV of the REACH Regulation. 
•	5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 
•	4,4’-Diaminodiphenylmethane (MDA) 
•	Alkanes, C10-13, chloro (SCCPs) 
•	Hexabromocyclododecane (HBCDD) (and all major diastereoisomers identified, i.e. á, â and ã-HBCDD) 
•	Bis(2-ethylhexyl) phthalate (DEHP) 
•	Benzyl butyl phthalate (BBP) 
•	Dibutyl phthalate (DBP)

Based on the information given in ECHA’s prioritisation and justification documents and following consultation with other relevant national authorities in Ireland, IE would have no objection to the inclusion of these 7 substances in Annex XIV.	Thank you for this information.	
20090409	MSCA, Poland	We support recommendation of Alkanes, C10-13, chloro (SCCP) as a priority for inclusion in Annex XIV. We agree that SCCP meets criteria ‘PBT and vPvB properties’ and ‘wide dispersive use’ and ‘relatively high volumes’ to its prioritisation for inclusion in Annex XIV.	Thank you for this information.	
20090414	Allgemeine Unfallversicherungsanstalt (on behalf of), national authority, Austria, 	The exemptions of concentrations lower 1% in preparations are not agreed. SCCPs should be integrateted into the auth. process with the clear aim to fade out any use of SCCPs. 	We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions, Article 58(2) could be used to exempt that specific use. We see two such situations: 

i) Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply

ii) Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.  
	
20090414	Instituto Sindical de Trabajo, Ambiente y Salud (ISTAS) (on behalf of), national NGO, Spain,	ETUC General comments: The prioritisation proposed by ECHA has been developed on the basis of the available information on intrinsic properties, uses, releases and volumes of the substances of very high concern on the Candidate List . According to article 58(3) priority for inclusion in Annex XIV shall normally be given to substances with: a) PBT or vPvB properties; or b) wide dispersive use; or c) high volumes. ECHA states that: “Given that the listing of the criteria is connected by the term ‘or’, this means that meeting one criterion could in principle be sufficient to prioritise a substance for inclusion in Annex XIV. However, in order to allow further differentiation the approach actually followed for prioritising the candidate substances for inclusion in Annex XIV also considers how many of these three criteria are met by the candidate substance concerned and to what degree”. However, in ETUC's opinion ECHA has not followed a clear and comprehensive methodology for prioritizing substances and the justification that has been given in some cases is not in accordance with the announced criteria. For example, ECHA has justified not to prioritize several substances due to the lack of information on releases (sodium dichromate, cobalt dichloride, diarsenic pentaoxide) or to the lack of information on safer alternatives (cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide and sodium dichromate). These reasons for non prioritization are also not in accordance with the Precautionary Principle stated in the REACH recital (69): “To ensure a sufficiently high level of protection for human health, including having regard to relevant human population groups and possibly to certain vulnerable sub-populations, and the environment, substances of very high concern should, in accordance with the precautionary principle, be subject to careful attention.” In ETUC's view, complete information on alternatives and releases shall be generated by the company asking for authorization for a certain use, and should not be a criteria for not including a SVHC in the Authorization list. In addition, we consider that the Prioritization criteria used by ECHA do not take into account workers health when considering human exposure. Only consumer exposure has been considered and used as justification not to prioritize several HPV substances (triethyl arsenate, anthracene, diarsenic pentaoxide, diarsenic trioxide, sodium dichromate and lead hydrogen arsenate). However, these susbstances are of high importance for workers health and are known to cause recognized work-related diseases at Community level (Commission Recommendation of 19 September 2003 concerning the European schedule of occupational diseases (notified under document number C(2003) 3297) (Text with EEA relevance) (2003/670/EC) ANNEX I). In order to better take into consideration worker's health and given that in Article 58(3) the term "normally" implies that the criteria mentioned do not need to be seen as exclusive, ETUC suggests that ECHA should take into account an additional criterion for prioritising SVHC in the Annex XIV. This criterion should be the existence of recognised occupational diseases linked to the SVHCs. ETUC has recently proposed a methodology to prioritise SVHC taking into account this specific criterion (see attached document). The Trade Union Priority List for REACH Authorisation includes 306 HPVC entries also ordered by score by reference to their intinsic eco-toxicological properties. We believe that if those chemicals are included in the candidate list and subsequently prioritised in the Annex XIV, it would surely promote the development of safer alternatives and cut both the incidence of chemical-related occupational diseases and the attendant costs for the Community, workers and industry itself.

+ see attachment	We do not agree with the statement that in developing/applying ECHA’s prioritisation approach the precautionary principle and/or worker’s health were not taken into consideration. From the published description of the prioritisation approach (‘General Approach for Prioritisation of Substances of Very High Concern for Inclusion in the List of Substances Subject to Authorisation’, one of the documents used by ECHA for preparation of its Recommendation) it should be concluded that information on occupational health has been taken into account.

It further seems to be a misunderstanding of ECHA’s explanations regarding the priority of particular candidate substances to claim that ECHA had justified not to prioritise several substances with lack of information on releases (sodium dichromate, cobalt dichloride, diarsenic pentaoxide) or with lack of information on safer alternatives (cobalt dichloride, diarsenic pentaoxide, diarsenic trioxide and sodium dichromate), and by doing so had violated the precautionary principle. Decisive factor for non-prioritisation of all above mentioned metal salts and oxides was not uncertainty about exposure or alternatives but the possibility that these substances could be easily replaced by other salts or forms of the metal with the same or a similar hazard potential, which would render any authorisation measures imposed solely on the mentioned substances ineffective unless the closely related compounds could as well be subjected to the authorisation requirement in a grouping approach. This requires however first the development of Annex XV dossiers for the similar metal compounds and their identification as SVHC in accordance with Article 57.

Your proposal on consideration of further prioritisation criteria and the supplementary information on ETUC’s prioritisation will be taken into account in the further development of the prioritisation approach developed by ECHA.	

Substance specific comments related to prioritisation
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090217	MSCA Luxembourg	We support the prioritisation of SCCP for inclusion in Annex XIV.	Thank you for this information.	
20090313	Company (on behalf of), Germany	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_sccps.pdf, page 3, section "5.Proposed exempted categories of use". Proposal: To exempt from the authorisation requirement the placing on the market of SCCP in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Our company does currently not have industry data with respect to volumes or concentrations of SCCP used in analytical standards, but is committed to provide a constant stream of new measurement solutions to the environmental measurement market place.	According to Art. 56(3) of the REACH Regulation, the obligations of Art. 56(1) and 56(2) “shall not apply to the use of substances in scientific research and development”.
Hence, as defined in Art. 3(23) of REACH the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year does not require authorisation.
ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use does not require an authorisation.	
20090324	MSCA, The Netherlands	SCCP: NL agrees with ECHA’s opinion to prioritize this substance, in our ranking the substance scored high priority (9) based on the following criteria: 1) PBT/vPvB (score 1) 2) Actual use, estimated at 	Thank you for this information.	
20090402	MSCA, Norway	N agrees on the prioritisation of SCCP for inclusion in Annex XIV .The substance has been identified as a PBT and vBvP substance. Furthermore the known end-uses of SCCP are likely to be widespread and associated with a high potential for release of the substance. The use of SCCP can therefore be considered as wide dispersive, which is supported by the extensive documentation that SCCP is found widespread in the environment, it has also been detected in the Arctic (Addendum RAR 08). The prioritisation of SCCP is in accordance with the Article 58(3)(a) and (b).	Thank you for this information.	
20090414	MSCA, Sweden	We support the prioritisation of SCCP for inclusion in Annex XIV. The substance fulfils all three of the criteria for prioritisation mentioned in REACH Art. 58.3 – PBT/vPvB, wide dispersive use and (relatively) high volume.	Thank you for this information.	
20090414	Instituto Sindical de Trabajo, Ambiente y Salud (ISTAS) (on behalf of), national NGO, Spain 	The ISTAS do agree with the prioritisation stated by ECHA for this substance.

+ see attachment	Thank you for this information.	

II - comments and responses to comments on the draft Annex XIV entries 

General comments on the justification
Date 	Submitted by (name, Organisation/MSCA)	Comment	Response	
20090406	MSCA, United Kingdom	The UK REACH CA sent in comments by the end of February, as requested by the MSC secretariat. Within the UK there has also been consultation across all relevant governments departments and devolved administrations within the UK. As a result, some additional comments have been collected. These are indicated below – along with repeating the earlier comments from the CA, so as to keep everything together. The additional comments do not change the previous “UK” position on SCCPs.	Thank you for this information.	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF) (on behalf of), international NGO, Belgium 	CHEM Trust, Greenpeace, HEAL and WWF support the prioritisation for inclusion in Annex XIV due to the PBT/vPvB properties and wide dispersive uses. Given the similar hazardous properties of MCCPs, which are often used as replacements, we believe that controls for MCCPs need to urgently follow as soon as possible. ECHA already recognised the importance of preventing the substitution to other hazardous chemicals in the context of some of the metal compounds (so called ‘grouping approach’). 	Thank you for this information.
As regards the request to impose controls on MCCPs as soon as possible, please note that MCCPs are not formally identified as Substance of Very High Concern (SVHC) and therefore no candidate substance, which is a prerequisite for subjecting a substance to the authorisation requirement. The initiative for starting the procedure to identify a substance as a SVHC meeting the criteria of Article 57 and to get it on the candidate list is up to the Member States or the European Commission.	
20090408	MSCA, Ireland	We can support the proposed transitional arrangements, proposed review periods for certain uses (where applicable) and the proposed exempted (categories of) uses (where applicable).	Thank you for this information.	
20090409	MSCA, Austria	The Austrian CA supports the inclusion in Annex XIV on the basis of the comments on the justification paper.	Thank you for this information.	
20090409	MSCA, Germany	The German CA supports the justification document. SCCPs clearly fulfill the criteria of REACH article 58(3)to be recommended with priority for inclusion in Annex XIV.	Thank you for this information.	
20090414	Individual, United Kingdom	The wide dispersal, high volume and well-established PBT characteristics of chlorinated paraffins (CP) argue for a more rapid phase-out than you have proposed despite prioritizing SCCP. You will be aware of SCCP toxicity summaries such as: 1. Bolliger, R., Randegger-Vollrath, A. 2003. Kurzkettige chlorierte Paraffine - Stoffflussanalyse. Schriftenreihe Umwelt Nr. 354. Bundesamt für Umwelt Wald u. Landschaft (BUWAL). Bern; 2. Stockholm Convention listing draft risk profile, http://www.pops.int/documents/meetings/poprc/drprofile/drp/DraftRiskProfile_SCCP.pdf But you may be unaware that levels of short & medium-CCP were in--and their relative levels were similar to--almost all of the samples of human milk fat in a general population (Thomas G.O. et al. 2006 Environ. International:32:1:34-40), If unaware of this data, such widespread human body burdens add to the need to phase-out CP more rapidly. Once again, however, you cannot assess risks individually and fulfill your REACh Authorization mandates. Rather you must assess CP risk cumulatively, at realistic doses, and especially during vulnerable development. --	We take note of the concerns raised regarding the potential additive or cumulative effects that may occur as a result of exposure of humans or the environment to different substances at the same time. The actual assessment of the magnitude of the potential risks that may occur through combined exposure is highly complex and needs substantial knowledge in terms of the exposure profile (which substances to take into account, at what level does the exposure occur and what is the spatial variability). In addition, in cases where the exposure profile would be known, knowledge on the potential interactions that the different substances have in humans or environmental species needs to be known in order to be able to fully assess the potential effects of the combined exposure. 

Authorisations will be granted to specified actors (this can be manufacturers, importers or downstream users) who need to describe in their application the specific use or uses of the substance for which they request an authorisation. The Commission shall grant an authorisation if the risk to human health or the environment arising from the use of the substance is adequately controlled or, for substances falling under article 60(3), may grant an authorisation if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. 

Taking into account this direct link between the actor, the use and the substance, it is difficult to envisage how in the decision-making process on an authorisation application for a specific substance the potential combined effects caused by exposure to other substances (which may or may not fall under the authorisation regime) can be taken into account. 

A potential exemption to the situation described above might be where the applicant makes use of the provisions provided for in article 62(3) and submits an application dossier for a group of substances (fulfilling the requirements of section 1.5 of Annex XI). In cases where the applicant has based his grouping argumentation on a similar mode of (toxicological or ecotoxicological) action of the members of the group it could be expected that in the chemical safety assessment for this group the effects of potential combined exposure will also be addressed and therefore can be taken into account in the decision-making process. 	
20090414	Mediterranean Information Office for Culture, Environment and Sustainable Development (MIO-ECSDE), international NGO, Greece	MIO-ECSDE is for the prioritisation for inclusion in Annex XIV due to their PBT/vPvB properties, wide dispersive uses and their potential for long range environmental transport. SCCPs are found to be highly toxic to aquatic organisms. They do not break down naturally and tend to accumulate in biota. Their persistence, bioaccumulation, potential for long-range environmental transport and toxicity support the fact that they may have damaging environmental effects at a global level. 	Thank you for this information.	
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the transitional arrangements as proposed by ECHA. 	Thank you for this information.	

Transitional arrangements: comments on the proposal and conclusion
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090406	MSCA, United Kingdom	Earlier UK REACH CA comments: none. Additional comments received: In the documentation available, MCCPs appear to be the main substitute for the remaining applications, but these are also potentially PBT substances, which perhaps could be emphasised more (it is stated that for MCCPs no PBT assessment is available, quoting the 2005 ESR RAR, but an assessment is included in the 2008 report as well as the Annex XV dossier on SCCPs). A number of brominated flame retardants are mentioned as possible alternatives in the textile sector, although our understanding is that some organisations made a positive decision to switch from those to chlorinated paraffins to be ‘bromine free’ for marketing reasons. At least one (HBCDD) is also a candidate for Annex XIV, which presumably means it would not be a suitable alternative. DEHP is listed as a potential alternative for sealants/adhesives, with a statement that a PBT assessment has not been carried out; as it is a candidate for Annex XIV, it is presumably not a suitable alternative? We wonder if the phthalates are real substitutes for SCCPs?	The information collected by ECHA and its consultants about alternatives to the proposed substances does not aim to identify potential alternatives or to assess the technical or economic feasibility of such alternatives or the risks related to them. The information is collected (and presented) to obtain an overview of the level of information available on the alternatives and the nature of the alternatives. In other words, this part of the assessment is not judging whether the alternatives are feasible or safer or how long it could take to transfer to the alternatives, but whether or not information seems to be available that facilitates compiling an analysis of alternatives by the future potential applicants. 

As far as your specific comment on SCCPS is concerned, we would like to stress that the availability and suitability of alternatives are no criteria that have been taken into account by ECHA for prioritising substances for inclusion in Annex XIV. The respective information may be provided as part of the applications for authorisation that will have to be submitted to ECHA (art. 62.4 (e) – analysis of alternatives) and will be discussed and taken into account in the decision procedure on authorisations (Art. 64).	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF) (on behalf of), International NGO, Belgium	Page 2 The timelines foreseen for transitional arrangements are too long and should be shortened to 18 months application date and 36 months (sunset date), respectively, after the date of inclusion in Annex XIV, as foreseen in the Guidance on inclusion of substances in Annex XIV (p.35). Moreover, the substance has been long known as having persistent and bioaccumulative and toxic properties and voluntary agreements with industry have been running for several years. 	The reasons for proposing as the earliest application date 24 months from the inclusion of the substance into Annex XIV are explained in the document ‘General Approach for Defining the Annex XIV entries’, which is being published as a supplementary document to ECHA’s Recommendation. As for the grounds for further extending this minimum period for SCCPs, these are provided in Annex I of ECHA’s Recommendation (substance specific document C).
On the basis of the information available, ECHA does not see grounds for proposing shortening the application and sunset dates for Alkanes,C10-13,chloro.	
20090414	Mediterranean Information Office for Culture, Environment and Sustainable Development (MIO-ECSDE), international NGO, Greece	The timelines foreseen for transitional arrangements should be shortened to 18 months for the application date and 36 months for the sunset date after the date of inclusion in Annex XIV.
	The reasons for proposing as the earliest application date 24 months from the inclusion of the substance into Annex XIV are explained in the document ‘General Approach for Defining the Annex XIV entries’, which is being published as a supplementary document to ECHA’s Recommendation. As for the grounds for further extending this minimum period for SCCPs, these are provided in Annex I of ECHA’s Recommendation (substance specific document C).
 On the basis of the information available, ECHA does not see grounds for proposing shorter application and sunset dates for Alkanes,C10-13,chloro.	
20090414	MSCA, Sweden	We agree to the proposal of 27/45 months application/sunset dates. The justification seems appropriate.	Thank you for this information.	
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the transitional arrangements as proposed by ECHA. 	Thank you for this information.	

Transitional arrangements: comments on the justification
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090414	MSCA, Sweden	See above (i.e. MSCA Sweden’s comment under heading ‘Transitional arrangements: comments on the proposal and conclusion’)	See response to comment referred to.	

Uses (or categories of uses) exempted : comments on the uses proposed to be exempted
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090407	WWF (on behalf of CHEM Trust, Greenpeace, HEAL and WWF) (on behalf of), international NGO, Belgium	Page 3 We disagree with the proposed exemptions which still allow the placing on the market of SCCP in preparations in concentration at or lower than 1 % by weight for use in metalworking and in fat liquoring of leather. Uses up to 1 % can theoretically still lead to significant PBT releases. Therefore, we do not think it is a convincing argument only because this was already permitted under Directive 76/769. Moreover, ECHA’s background report says on page 18 that such applications are “technically not expected” which also supports the deletion of this exemption.	We agree that an exemption from the authorisation requirement under Article 58(2) would not be satisfied solely on the basis that Annex XVII includes (some kind of) restriction on the substance. However, where an entry in Annex XVII exempts a specific use of a substance from the restrictions, Article 58(2) could be used to exempt that specific use. We see two such situations: 

i) Annex XVII includes a restriction on a specified use of a substance and this restriction specifies condition(s) under which the restriction does not apply

ii) Annex XVII includes a generic ban on a substance and a specified use is exempted from this generic ban. Such an exemption can be subject to further conditions.  

In the draft recommendation the proposed exemption from the authorisation requirement on SCCPs is based on case i) and the proposed exemptions on DEHP, DBP, BBP and MDA are based on case ii). 

We believe that in such cases an assessment must have been made by the Community legislator in deciding to what extent such specific uses should be restricted leading to the specific entries made for such uses in Annex XVII (formerly Directive 76/769). 

In ECHA’s view the authorisation process should not put into question such assessments made by the Community legislator in the restrictions process. Indeed, recital 80 of the REACH Regulation provides that ‘The proper interaction between the provisions on authorisation and restriction should be ensured in order to preserve the efficient functioning of the internal market and the protection of human health, safety and the environment. Restrictions that exist when the substance in question is added to the list of substances, for which applications for authorisation can be submitted, should be maintained for that substance. …’

The proposed approach guarantees a proper interaction between the two instruments.

However, if exemptions, derogations or conditions included in the entries of Annex XVII are of concern and further measures may be needed to address these concerns, a revision of these entries should have been initiated.	
20090414	MSCA, Sweden	We have difficulties agreeing with the argumentation for the exemption for SCCP in metal working fluids and in fat liquoring of leather in preparations at < 1% based solely on the fact that such use is permitted under the limitations directive. Directive 76/769/EEC stipulates prohibitions with exemptions while authorisation under REACH may or may not result in the granting of authorisation depending on e.g. the level of control of risks. Thus, any analysis of advantages and drawbacks, risks, alternatives etc. that was relevant in deciding not to ban SCCP in some low concentration preparations under the limitations directive is not necessarily relevant in deciding whether these uses of the substances should be exempted from authorisation. 		
20090414	MSCA, The Netherlands	The Netherlands CA agrees with the uses exempted from the authorisation requirement as proposed by ECHA.	Thank you for this information.	

Other uses (categories of uses) to be exempted and existing Community legislation imposing on this (category of) use of the substance minimum requirements relating to the protection of human health or the environment
Date 	Submitted by (name, Organisation/MSCA)	Comment 	Response	
20090326	Company (on behalf of), Germany	Document reference: http://echa.europa.eu/doc/consultations/recommendations/justifications/justif_sccps.pdf, page 3, section "5.Proposed exempted categories of use". Proposal: To exempt from the authorisation requirement the placing on the market of SCCP in a preparation for the supply to industrial users for the use as analytical standard for test and measurement instruments. Justification: Defined substance samples are required to calibrate analytical instruments to identify and quantify the substance (e.g. for measurement solutions used by enforcement agencies). The applications are laboratory use by professional users (minimal risk to consumers and the environment, controlled professional use and disposal). The volumes required for calibration samples (analytical standards) are minimal, typically a solution in the range of millilitres. The concentration of the chemical standard substance is normally low - in the range of 0.1%-2% and often lower according to the sensitivity of the measuring technique. For existing or future development of new highly sensitive analytical test solutions (e.g. using mass spectroscopy, chromatography, optical spectroscopy, etc.), the use of analytical standards for calibration purposes is indispensable and is required for deployment of technical verification instruments for operational enforcement of environmental policies. A substitution of the substance of concern is technically not possible due to the calibration purpose of the usage. Our company does currently not have industry data with respect to volumes or concentrations of SCCP used in analytical standards, but is committed to provide a constant stream of new measurement solutions to the environmental measurement market place. Comment on Terminology: Analytical standards are sometimes also named chemical standards, calibration standards, reference standards or samples or test samples.	According to Art. 56(3) of the REACH Regulation, the obligations of Art. 56(1) and 56(2) “shall not apply to the use of substances in scientific research and development”.
Hence, as defined in Art. 3(23) of REACH the placing on the market of a substance for any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year does not require authorisation.
ECHA is of the opinion that, provided that the use of the substance is actually in accordance with the definition of “scientific research and development” under REACH, and in particular fulfils its specific conditions, the placing on the market for this specific use does not require an authorisation	

Information on the need to exempt PPORD from the authorisation requirement, including the maximum tonnage – NO COMMENT RECEIVED

Review periods – NO COMMENT RECEIVED

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