COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFICATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name: Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)
CAS number: -
EC number: -

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Endocrine disrupting properties (Article 57(f) - environment)

Disclaimer: Comments provided during public consultation are made available as submitted by the commenting parties. It was the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a substance of very high concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5276
2019/04/18	Health and Environment Alliance (HEAL),
International NGO,
Belgium	-	See response to specific comments below.	
		Attachment: 5276_HEAL-comments-TNPP.pdf
		
5307
2019/04/29	United Kingdom,
Member State	Restrictions limiting the percentage of 4-NP in substances, mixtures and articles that are supplied to the market might be a more straightforward regulatory option for stakeholders to comply with and authorities to enforce. A restriction may potentially also give a greater environmental benefit (since it could address multiple sources). There is no need to seek Candidate Listing of individual substances before producing such a proposal.

If the intention is to include TNPP on Annex XIV then there should be some consideration of the impact on RAC and SEAC as this substance is supplied in high volumes and has a large number of uses so there would potentially be a significant number of authorisation applications.

We realise these are not specific issues for an SVHC decision, but we still think they are relevant in this case.	The option of a restriction limiting 4-NP is under consideration and will be further evaluated in the context of a larger RMOA for substances that contains 4-NP, under development. Such a restriction can be proposed in addition to the SVHC identification of TNPP and the interest of this approach is therefore not in contradiction with the current proposal for SVHC identification. 
Although the concern for the RAC and SEAC workload is acknowledged, the criteria for priorisation to Annex XIV do not depend of the MSCA in charge of the SVHC identification. In the contrary, it was agreed by the MSC that a higher tonnage is one of the criteria for priorisation.

The proposed SVHC identification is in line with the fact that 4-NP is considered also as a “priority hazardous substance” under the Water Framework Directive 2000/60/EC (WFD) for which, at the community level nonylphenol discharge/emission/loss must cease or be phased out by 2026. This proposal is in particular intended to prompt the use of NP-free TNPP. It justifies to act without undue delay.
It also fulfil the criteria of the SVHC roadmap 2020.	
		-		
5308
2019/04/29	Environment Agency Austria (EAA),
Other contributor,
Austria	Environment Agency Austria supports the French proposal to identify Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) as Substance of very high concern as a step in the reduction of nonylphenol exposure.	Thank you for the support.	
5310
2019/04/29	Phosphites Stabilisers REACH Consortium,
Industry or trade association,
United States	See attached comments.	Responses to your specific comments are provided in the two next tables below (next table for comments related to the justification, last table for comments related to Part II of the Annex XV dossier).	
		Attachment: 5310_PSRC Comments on TNPP SVHC Proposal - 29 April 2019.pdf
		
5311
2019/04/29	ChemSec,
International NGO,
Sweden	ChemSec agrees to include these substances to the Candidate List, as the group 4-nonylphenol branched and linear were already in 2012 identified as SVHCs, based on being endocrine disruptors in the environment.	Thank you for the support.	

Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5271
2019/04/12	European Environmental Bureau,
International NGO,
Belgium	EEB supports the proposal to identify Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) as SVHC based on its endocrine effects in the environment (art 57f). MSC agreed in 2012 that 4-nonylphenol, branched and linear, meets the criteria to be identified as SVHC due to endocrine disrupting properties in the environment.  Therefore, the group of tris(4-nonylphenyl, branched and linear) phosphite (TNPP) containing ≥ 0.1% w/w of 4- nonylphenol, branched and linear (4-NP), should also be identified as substances of very high concern due to their endocrine disrupting properties in the environment.	Thank you for the support.	
5273
2019/04/15	Germany,
Member State	The German CA supports the SVHC identification of the substance since it contains ≥ 0.1% w/w of 4-nonylphenol, branched and linear. 4-nonylphenol, branched and linear, has been identified as a group of substances with endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment which gives rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 REACH.
Additionally, we propose to add any data available on the degradation of the TNPP moiety to the dossier. In our point of view it is likely that TNPP can be hydrolysed under environmental conditions or via active metabolism in various organisms. This would yield three moieties of 4-NP per molecule of TNPP. Hence, if such degradation pathways can be proven the substance TNPP could also be identified as SVHC even if the content of free 4-NP can technically be decreased under 0.1%w/w.	Thank you for the support.

We share your concern regarding the possible release of 4-NP from TNPP. However, the current database do not enable to demonstrate this hydrolysis and further information is requested on this concern in the context of the ongoing SEv for the registered TNPP. It is therefore considered premature to add this information in the current SVHC identification dossier. Independently of this request, it is proposed to regulate TNPP on its impurity before regulating on its metabolisation, if confirmed. 	
5276
2019/04/18	Health and Environment Alliance (HEAL),
International NGO,
Belgium	HEAL fully supports the proposed identification of this substance as a substance of very high concern, due to its endocrine disrupting properties for the environment.
We would like to make the following comments:
- 4-nonylphenol, branched and linear, was already identified as a group meeting the SVHC identification criteria due to its endocrine disrupting properties for the environment by the MSC in 2012. Therefore we believe that Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) that contains ≥ 0.1% w/w of 4-nonylphenol (4-NP), branched and linear should also be identified as such.
- As mentioned in the supporting dossier, the group of 4-NP is already included in the candidate list and a detailed assessment of the environmental fate properties as well as of the environmental hazard assessment have been made available in order to support identification as an SVHC. These assessments are still fully valid in the context of the identification of TNPP (See “Member State Committee support document11 for identification of 4-nonylphenol, branched and linear (4-NP) as substances of very high concern because of its endocrine disrupting properties which cause probable serious effects to  the  environment  which  give  rise  to  an  equivalent  level  of  concern  to  those  of  CMR  and PBT/vPvB  substances”,  adopted  by the MSC on  13  December  2012).
- We also support the statement made in dossier that “4-NP is considered also as a “priority hazardous substance” under the Water Framework Directive 2000/60/EC (WFD) for which, at the community level, nonylphenol discharge/emission/loss must cease or be phased out by 2026. This means that there is political agreement that 4-NP is a high priority for ongoing aquatic emission reduction at EU level.” And therefore, SVHC identification of TNPP including ≥ 0.1% w/w of 4NP should be part of the effort to reduce release into the environment in the long-term.	ANSES agree with your comments. 	
		See the corresponding embedded attachment in table 1 of Part I: 5276_HEAL-comments-TNPP.pdf		
5289
2019/04/26	CHEM Trust Europe,
National NGO,
Germany	CHEM Trust supports the identification of tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) as an SVHC based on its endocrine disrupting effects on the environment according to REACH article 57 f.
4-nonylphenol, branched and linear, has already been included in the REACH candidate list in 2012 following its identification as a group of substances with endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment which gives rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 REACH.

Therefore TNPP containing any constituent or group of constituents (including impurities) of the group “4-nonylphenol, branched and linear” ≥0.1% in total should also be identified as an SVHC and included in the REACH candidate list.	Thank you for your support.	
5296
2019/04/29	Norway,
Member State	4-nonylphenol, branched and linear (4-NP) has already been identified as a group of substances of very high concern. This is due to their endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment (Article 57(f)) and they were included in the Candidate list in December 2012.

Therefore, the Norwegian CA supports that tris (4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) likewise should be identified as substances of very high concern due to their endocrine disrupting properties to the environment and should be included in the Candidate List.	Thank you for your support.	
5304
2019/04/29	Netherlands,
Member State	In general we agree that it may be a proportionate regulatory measure to identify substances and UVCBs as SVHC when they contain an impurity that is identified as SVHC and is present in > 0.1%. As this is the case for the commercial grade TNPP we in principal agree with the SVHC identification on the basis of the presence of > 0.1% 4-NP. The current dossier lacks, however, the information to conclude on the proportionality of such SVHC identification. Preferably, we would have seen additional information on the scope of the concern. Considering the amount of 4-NP detected at some locations in the environment, the urge to act quickly is understood. However, it remains unclear whether TNPP is a significant source of 4-NP in the environment. Furthermore it remains unclear when further results from the Substance Evaluation process are expected to motivate that SVHC identification should not await these outcomes. It is not yet clear whether there is a possibility to produce a grade of TNPP without >0.1% of 4-NP. It would help the SVHC decision making if the dossier submitter could add this information to the proposal.	Your position is noted.

It is not known in details how much TNPP’s content in 4-NP contributes to the presence of 4-NP in the environment. However, data available from public sources on the Internet indicates that TNPP can be produced without 4- NP (or below 0.1%). 

 The presence of 4-nonylphenol in the monitoring data from France and other EU Member States indicates that the substance continues to be widely emitted from industrial and domestic sources and arrives subsequently to the rivers. It shows that environmental exposure to 4-NP still occurs despite the existing regulatory measures. The proposed SVHC identification is in line with the fact that 4-NP is considered also as a “priority hazardous substance” under the Water Framework Directive 2000/60/EC (WFD) for which, at the community level nonylphenol discharge/emission/loss must cease or be phased out by 2026. In this context, any risk management measure that can contribute to reduce environmental release of 4-NP is considered justified. The present proposal of SVHC identification is in particular intended to prompt the use of NP-free TNPP. It justifies to act without undue delay.

The result of the SEv process are not expected before 2 to 4 years. It may ultimately trigger the need for an additional SVHC dossier for TNPP whatever its impurity content. However, it is considered that the current situation already justifies a regulatory action toward environment protection and cannot be delayed for years awaiting for the SEV results that may or may not trigger additional action.

Further to your comment, information has been added in the Support document on the possibility to produce TNPP with 4-NP below 0.1%. This information is available from public sources on the Internet.	
		-		
5307
2019/04/29	United Kingdom,
Member State	We thank France for producing this dossier however, we are not convinced that it is appropriate to add this substance to the Candidate List at the present time. Further degradation testing has been requested under Substance Evaluation to clarify whether TNPP can transform to 4 nonylphenol (4-NP) in the environment, and we think it would be sensible to wait for that work to be completed before deciding whether Candidate Listing is a useful risk management measure.

We acknowledge that there is a precedent for the addition of substances to the Candidate List because they contain an existing SVHC above 0.1 % w/w (i.e. reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear). However, in that case, the 4-heptylphenol content of the commercial product was significantly above 0.1 % w/w. It is questionable what contribution TNPP makes to the environmental load of 4-NP, and hence what contribution it may make to environmental endocrine disruption. The Annex XV dossier does not attempt to explain this. It would therefore be useful to:

1. Present more detailed information about the composition of the currently registered grades of TNPP. Looking at the classification and labelling section of the TNPP registration dossier on ECHA’s dissemination portal (for the originally used CAS 26523-78-4), it appears that 4-NP may be present up to 5 %. A more highly purified grade containing < 0.1 % 4 NP was reportedly available at the time of the Existing Substances Regulation assessment.  Are there technical or economic challenges for supply chains to switch to the more highly purified grade? For example, does the production of the purer grade require additional energy in the purification step or is additional waste produced?

2. Explain what proportion of registrations report the presence of 4-NP at levels above and below 0.1 % and the tonnage involved (of both TNPP and 4-NP).

3. Explain the scale of 4-NP releases from TNPP compared to other sources.

TNPP is also used in a wide range of articles and this leads to some further complications. Addition to the Candidate List will create a legal obligation on article suppliers where the whole substance is present in articles at a concentration of 0.1 % or more. However, the concentration of the substance of actual concern (4-NP) may be orders of magnitude below this threshold. This creates the following issues:

• If a supplier of an article identifies that it contains TNPP, how can they determine the percentage of 4-NP that was present in the grade of TNPP that was used to manufacture their article? Are analytical methods sufficiently sensitive to enable 4-NP to be used as a marker for the whole UVCB substance where 4-NP itself may be present in mixtures/articles at a concentration well below 0.1 %?
• Is it possible that 4-NP may be present in the mixture/article from other sources? This could complicate the interpretation of any analytical data.
• Is there a good understanding of the variability of the concentration of 4-NP in commercial TNPP products so that conclusions about the concentration of the relevant “grade” of TNPP in mixtures and articles is legally enforceable?

We are concerned that the ability of article suppliers to comply with obligations arising from the inclusion of such an entry in the Candidate List has not been fully considered. Until these issues are resolved, we think the proposal to identify TNPP with ≥ 0.1 % w/w of 4-NP as an SVHC is premature.	Your position is accounted for.

The result of the SEv process are not expected before 2 to 4 years. It may ultimately trigger the need for an additional SVHC dossier for TNPP whatever its impurity content. However, it is considered that the current situation already justifies a regulatory action toward environment protection and cannot be delayed for years awaiting for the SEV results that may or may not trigger additional action.

It is not known in details how much TNPP’s content in 4-NP contributes to the presence of 4-NP in the environment. However, data available from public sources on the Internet indicates that TNPP can be produced without 4- NP (or below 0.1%).
The presence of 4-nonylphenol in the monitoring data from France and other EU Member States indicates that the substance continues to be widely emitted from industrial and domestic sources and arrives subsequently to the rivers. It shows that environmental exposure to 4-NP still occurs despite the existing regulatory measures. The proposed SVHC identification is in line with the fact that 4-NP is considered also as a “priority hazardous substance” under the Water Framework Directive 2000/60/EC (WFD) for which, at the community level nonylphenol discharge/emission/loss must cease or be phased out by 2026. In this context, any risk management measure that can contribute to reduce environmental release of 4-NP is considered justified. The present proposal of SVHC identification is in particular intended to prompt the use of NP-free TNPP. It justifies to act without undue delay.
 
The comments on the complexity of legal obligations are noted. One of the aim and benefit of REACH is to increase communication in the supply chain and SVHC identification can contribute to this objective by increasing the pressure for substitution. In addition, the complexity of legal obligations should not be regarded as an obstacle to SVHC identification that is exclusively based on the characteristics of the substance. 

The purpose of the Annex XV dossier is dedicated to the demonstration that the substance fulfils the SVHC criteria.

		-		
5310
2019/04/29	Phosphites Stabilisers REACH Consortium,
Industry or trade association,
United States	See attached comments.	The comments on the justification relates mainly to the absence of consideration of the properties of TNPP itself. Indeed, the present SVHC identification is based on the presence of the SVHC impurity 4-NP. This is in line with previous case such as RP-HP (Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear) with regard to its 4-heptylphenol content and with article 56(6) of REACH.

The SEv process have been initiated to ask for additional data on TNPP on behalf of France. The evaluating member states  is also the one proposing the present SVHC identification. Both measures are conducted in parallel for the sake of efficiency. Indeed, SVHC identification targets the presence of the 4-NP impurity while the SEv request targets the properties of TNPP itself. The result of the SEv process are not expected before 2 to 4 years. It may ultimately trigger the need for an additional SVHC identification for TNPP whatever its impurity content. However, it is considered that the current situation already justifies a regulatory action toward environment protection and cannot be delayed for years awaiting for the SEV results that may or may not trigger additional action.

Comments were submitted on risks. However, the SVHC identification is not a risk based process but it is based on the characteristics of the substance and in this specific context on the content in 4-NP. In the same way, comments on the authorisation process are not relevant at the step of SVHC identification.

Regarding the threshold of 0.1%, it is consistent with article 56(6) of REACH.

Others comments related to legal questions were also submitted. However, they are not directly relevant to question the justification of the proposed SVHC identification.	
		See the corresponding embedded attachment in table 1 of Part I: 5310_PSRC Comments on TNPP SVHC Proposal - 29 April 2019.pdf		

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5268
2019/03/13	Meraxo AG,
Company,
Switzerland	It has to be noted that due to ED properties of the minor percentage of the UVCB, calculations of SVHC content for mixtures containing this substance have to be based on the specific content of 4-NP, not TNPP.	Noted.	
		-		
5276
2019/04/18	Health and Environment Alliance (HEAL),
International NGO,
Belgium	-	Noted	
		See the corresponding embedded attachment in table 1 of Part I: 5276_HEAL-comments-TNPP.pdf		
5289
2019/04/26	CHEM Trust Europe,
National NGO,
Germany	CHEM Trust considers that high priority should be given to consider further regulatory measures following the identification of TNPP as an SVHC. A summary of information from 2008 highlighted that TNPP is a high-volume chemical applied in several widespread dispersive uses as an antioxidant in polymers. Environmental emissions can be expected as well as professional and consumer exposure, including from food contact materials. Currently the substance is registered by 8 manufacturers in Europe, thus an identification of TNPP as an SVHC and potential further regulatory follow-up is of high relevance. This holds in particularly true as 4-NP is also a “priority hazardous substance” under the Water Framework Directive 2000/60/EC (WFD) for which, at the community level, nonylphenol discharge/emission/loss must cease or be phased out by 2026. This means that there is political agreement that 4-NP is a high priority for ongoing aquatic emission reduction at EU level and REACH is the most relevant instrument for further risk management measures.	Noted.	
5307
2019/04/29	United Kingdom,
Member State	Section 11.2: As a more highly purified grade of TNPP containing < 0.1 % 4-NP is thought to be available this should be mentioned here as an alternative to the form containing > 0.1 % 4-NP.	Noted and agreed.	
5310
2019/04/29	Phosphites Stabilisers REACH Consortium,
Industry or trade association,
United States	See attached comments	Your comment on outdated information on tonnage is noted although not directly related to the SVHC identification. It was included in the part II of the Annex XV dossier with the known limit of its outdated nature. It is unfortunate than updated data have not been submitted through public consultation and in the registration dossier.

Comments regarding use, exposure, alternatives and risks may, when relevant, be considered at later stages of the risk management process of the SVHC dossier.	
		See the corresponding embedded attachment in table 1 of Part I: 5310_PSRC Comments on TNPP SVHC Proposal - 29 April 2019.pdf