DIRECTORATE-GENERAL
JOINT RESEARCH CENTRE
Institute for Health and Consumer Protection
Unit: Toxicology and Chemical Substances
European Chemicals Bureau
Ispra, 6 December 2007
Doc: JM/19/2007
16th Joint Meeting
of the Competent Authorities for the implementation of
Council Directive 67/548/EEC (Dangerous Substances)
and
Council Regulation (EEC) 793/93 (Existing Substances)
11 December 2007
Venue: Centro Cultural de Belém, Room A, Praçado Império, LISBOA-Portugal
Concerns:Status Report – TC NES sub-group on PBT/vPvB Substances and POPs
Agenda Point:4.3
Action Requested:The Competent Authorities and stakeholders are invited to take note of the document and comment as appropriate.
1
Status Report: PBT/vPvB Substances
1.Introduction
On 19-21st November, 2007 the ECB organised and chaired the 11th meeting of the TCNES sup-group on the identification of PBT and vPvB substances. The meeting discussed general items, existing substances and POPs in an open session and biocides and new chemicals in closed sessions, respectively. This document reports the progress made in the open session and the closed session on new substances.
2.Open Session on General Items and Existing Substances
2.1.Status of Website publication and PBT-summary fact sheets
With respect to the substances agreed upon by May 2007, ECB reported that the overview text and the substance lists are ready and 12 summaries are already published on the ECB Website ( Eight more summary fact sheets drafted by UK would be ready by December 2007. The finalization of the summary fact sheets is at the moment depending on the activity of the Rapporteur MS. MS were highly encouraged to send their comments on the PBT summaries before the 15th of December to allow the finalisation of the work. The adoption by TC NES of the finalised fact-sheets will take place at the April 2008 meeting.
2.2.RIP 3.2-2 PBT drafting group
ECB informed about the status of the work under the RIP 3.2-2 PBT drafting group. The draft was presented at the last SEG 3.2-2 meeting in October 2007 and comments were received by several MS. A new document is made available via the ECB Website.
2.3.Discussion on POPs
Two candidates for the UN-ECE POP Protocol and Stockholm Convention were discussed:
(1) Dicofol (Substance no 44 of PBT list, DE)
Dicofol fulfils B and T criteria. P criteria and the long range transport were discussed. While dicofol is not persistent in water, the substance should be considered as persistent in soil. A compilation of the most important conditions of the (laboratory) studies on degradation in soil are available in the factsheet. The results show that: a) susceptibility of both dicofol isomers to degradation processes is different, and b) degradation of dicofol is strongly depending on the soil type and environmental conditions, especially pH of the soil. Dicofol meets also the criterion for long-range atmospheric transport of <1000 Pa and an atmospheric half-life of >2 days.
The PBT WG agreed that Dicofol is considered as a candidate for the UN-ECE POP Protocol and Stockholm Convention.
(2) Pentachlorophenol (CAS: 87-86-5):
Due to the absence of the rapporteur (Poland) the meeting had only a very short discussion on the documents presented. It was proposed to ask Poland to include a further assessment of the metabolites, to evaluate in detail the BCF studies with mussels and to discuss more in-depth the impurities. The discussion has been postponed to the PBT WG March '08 meeting.
2.4.Substance-by-substance evaluation
The discussions on existing substances was focussed on the high priority ESR substances (Musk Xylene, D4 and Anthracene), on substances which need further testing, and those which still need further evaluation before a final recommendation can be given.
Musk Xylene (MX, CAS N.81-15-2, NL). At the May'07 meeting the PBT WG agreed to provisionally assign MX as fulfilling P criteria. At the Nov'07 meeting NL informed that it has started to re-evaluate the T criterion. The T assessment based on human toxicological data was completed, but NL stated that the ecotoxicity aspect of the T re-evaluation was not yet finalised. The outcome of this assessment will be revisited at the next PBT WG meeting scheduled for March '08.
D4 (Substance no. 124 of PBT list, FIN/UK). New monitoring data was provided by IND and Norway. Therefore, a re-evaluation of the substance is necessary. FIN will update the factsheets and UK will send a report and invite MS to a Workshop on D4, D5 and D6 where both monitoring and modelling will be addressed.
Anthracene (Substances no. 27, 28, 29, 30, 31, 32 of PBT list, DE). DE informed that the evaluation of the new information will not change the assessment). The assessment will be finalised and send to TCNES and to SCHER.
2.5.Overall conclusions
As a result of a proactive cooperation by Industry, the WG has received new test proposals and some results from the testing have been made available. Based on the new information the WG proposed the following:
- 1 substance (no. 44 of the PBT list, Dicofol) is fulfilling the PBT and POP criteria, and the PBT WG proposed to send Dicofol to the UNECE POP protocol and the Stockholm Convention.
- 2 substances (no. 93 and 118) that were earlier provisionally deleted will be re-discussed at the March '08 meeting.
- 1 substance (Musk Xylene) will be re-visited for the T criteria.
- 1 substance (no. 11 Extracts (petroleum) heavy paraffin distillate solvent) is proposed to be further evaluated under REACH.
- 1 substances (no. 117 of the PBT list) to be deleted from the list due to not fulfilling PBT or vPvB criteria.
Annex 1 lists the actions arising from the meeting, and Annex II the status of the substances.
3.Closed Session on New Notified Substances
Since the PBT review programme for new substances began in 2004, a total of 94 substances have been screened for further assessment. Of these, 11 substances have been confirmed as PBT/vPvB (with recommendation for risk management), 16 substances have been deferred (i.e., no longer a priority, usually due to cessation of supply), and 37 substances have been cleared of PBT/vPvB status, leaving 30 substances currently under evaluation.
The above figures include screened PBT notified substances concluded by written correspondence during June and July 2007, and more recently during a sub-group meeting (21st November 2007). This latest meeting agenda listed 42 screened substances open for review at that date. The meeting confirmed 2 substances as PBT/vPvB, cleared 9 substances of PBT/vPvB status, and deferred 1 substance as no longer supplied.
The 9 substances cleared of PBT/vPvB status, included a group of structural analogues. For one substance the notifier provided data to demonstrate not P. This information was used to support the PBT assessment of 4 other substances with similar structure (which were evaluated as not P). After the meeting, UK CA questioned, whether this is possible in absence of a data share arrangement. The other CAs are invited to express there opinion on read-across & data share.
ANNEX I
Actions arising from 11th TC NES Subgroup Meeting on Identification of PBT and vPvB Substances - Existing Substances Session (19-20th November 2007)
DRAFT - 28 November 2007
No. / MS Rapporteur / CAS / Name / Description of the Action / Time Scale5 / AT / 118-82-1 / 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol / IND has submitted a WS study and a feasibility study. Ind will perform BCF test, OECD 308 with one concentration. / BCF study to be discussed at the next meeting.
15 / UK / 15571-58-1 / 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate / Relevant for 15, 16, 89 and 99.
UK: Industry have provided a progress report on the further work conducted to better understand the water chemistry of the dioctyl tin compounds and the characteristics of the degradation products that arise. The molecular dimensions of the DOT(EHTG)2 suggest that it may not bioconcentrate.
A preliminary study on absorption on fish, and uptake will be quickly available and OECD 305 test will be performed. The final report may be by final summer 2008. / An update on the problems to be presented at next meeting.
16 / UK / 3542-36-7 / Dichlorodioctylstannane
22 / NL / 50849-47-3 / 5-Nonylsalicylaldehyde oxime / NL informs the PBT WG about the progress made regarding the testing result of the inherent biodegradability test (OECD 302C). The result indicate to be not inherently biodegradable, however it will take ca. 2 weeks to get the final report.NL will wait for the evaluation of the report and discuss with IND how to proceed / Evaluation and results to be presented at March'08 meeting.
23 (b) / UK / 85535-85-9 / MCCP / OECD 305 will be performed. The test will start as soon as the protocol is agreed.
UK will circulate the protocol to TCNES and MS will have 2 weeks for commenting the protocol. The test should start on January. / .
Discussion at March'08 meeting
26 / UK / 91745-46-9 / Amines, C12-14-alkyl, reaction products with hexanol, phosphorus oxide (P2O5), phosphorus sulfide (P2S5) and propylene oxide / To park aside and to communicate that the PBT WG has not methods to assess it this kind of substances. / Parked
34 / ES / 68442-68-2 / Benzenamine, N-phenyl-, styrenated / Good progress with testing.. Ind will perform a fish dietary study for the di-styrenated and read across to the mono. Results on the BCF are expected for next meeting. / Discussion at March'08 meeting
35 / FR / 91696-73-0 / Benzenesulfonic acid, C14-44-branched and linear alkyl derives., calcium salts / Read across with a New substance
IND has informed that the new OECD 305 BCF study has not started yet: as technical problems have occurred, the synthesis of a radio labelled version of the New substance has not yet been completed.
Discussion took place in the closed New chemical's session on 21st Nov'07. / Discussion at March'08 meeting
36 and 63 / FR / 83846-43-9 / Benzoic acid, 2-hydroxy-, mono-C>13-alkyl derivs, calcium salts (2:1) / See also substance no 63
A reproduction study was initiated with a solution prepared with the 1000 mg/L loading. The study is in progress at this time, and preliminary results presented. No differences between normal fish and expose to the substance, test to be finalised by end December. FR would like to see the report before concluding about the results a proposal of not vPvB, not PBT is envisaged.
FR will send e-mail to PBT WG with the results of all toxicity data to be tabled and a proposal on how to proceed with the assessment. / IND to provide FR with the reproduction study results as soon as available.
Discussion at next meeting.
42 / UK / 31565-23-8 / Di(tert-dodecyl) pentasulphide / The rapporteur (UK) has provided new information regarding the evaluation of the industry approach to membrane transport modelling. The PBT WG asked for additional information like fish dietary test, uptake and toxicity data. The indicators developed tend to indicate not to bioaccumulate but the group asked for further information. The theoretical information alone is not sufficient to make a conclusion and asked UK to look at the available data from the US-HPV voluntary program. UK will discuss with IND which test is the best.
DK and ES will send their calculation (uptake, toxicity).
UK informed that the substance is foreseen as a replacement of SCCP. / The group asked for experimental data, to look at the categories approach.
Discussion is postponed to March'08 meeting.
44 / DE / 115-32-2 / Dicofol / Dicofol fulfils B and T criteria. P criteria and the long range transport was discussed. While Dicofol is not persistent in water, the substance should be considered as persistent in soil. A compilation of the most important conditions of the (laboratory) studies on degradation in soil are available in the factsheets. The results show that: a) susceptibility of both Dicofol isomers to degradation processes is different, and b) degradation of Dicofol is strongly depending on the soil type and environmental conditions, especially pH of the soil. Dicofol meets also the criterion for long-range atmospheric transport of <1000 Pa and an atmospheric half-life of >2 days.
. / The PBT WG agreed that Dicofol is a PBT and is in addition considered as a candidate for the UNECE POP Protocol and Stockholm Convention
63 / FR / 84929-98-6 / Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar'-di-C>13-alkyl derivs. / See substance no. 36.
71 / UK / 90481-05-3 / Phenol, nonyl-, manuf. of, by-products from, high-boiling / See substance no 103, substance 103 is more relevant for UK.
UK informed that the Ind will stop the supply of the substance. Therefore , RRM will have to be in place. The supplier is placed in Italy and Germany, UK will send the information to IT and DE who have to verify if the substance is effectively phased out. / Conclusion expected for March'08 meeting
79 / UK / 61788-44-1 / Phenol, styrenated / Substance is part of the list for the 12(2) Regulation.
See also substance 34
Protocol for fish feeding study agreed by UK rapporteur. WS and Log Kow definitive data. Study should begin in Nov 2007 and realise a BCF for the commercial product both DSP and TSP. / Results and discussion at March'08 meeting
86 / FIN / 26140-60-3 / Terphenyl / See substance 87
Substance on hold waiting for further information for substance 87 / On hold
87 / FIN / 61788-32-7 / Terphenyl, hydrogenated / At the May'07 meeting it was concluded that 87 fulfil B and vB criteria. The WG agreed that a simulation test (OECD 308 or 309) is necessary with the substance used in the METI test.
No new factsheets available at the Nov'07 meeting. There was not enough for starting a discussion. A test program needs to be defined. / FIN to prepare the update of the factsheet and to discuss the substance at March'08 meeting
88 / NL / 1461-25-2 / Tetrabutyltin / Substances are on the list for the 12(2) Regulation
88: NL has updated the factsheet. Substance forms under environmental condition the PBT substance tributyltin and therefore it is a PBT forming substance.Although it does ultimately degrade to inorganic tin oxide, the substance forms under environmental condition the PBT substance tributyltin, therefore it is a PBT forming substance.
IND added that TTBT is an intermediate used exclusively for the manufacture of tin stabilizers and catalysts. This substance is processed under strictly controlled conditions matching the REACH requirements for transported isolated intermediates. IND to complete RRM. A declaration will be written in a special form.
89:Substance: does not fulfil B criteria. The assessment should focus on the impurities dioctyltin (no. 16) that could be possible candidates for PBT properties.
See substance 15 + 16 / As soon as possible.
89 / NL / 3590-84-9 / Tetraoctyltin
93 / DE / 86089-17-0 / Tridecylamine, branched and linear / see substance 118
3/05/07: Substance is based on a pre-test provisionally de-listed. BCF < 1200. For final conformation that substance is not B waiting for the GLP study for no 118.
20/11/07: New information submitted by IND / Next meeting to discuss the report.
98 / UK / 25103-58-6 / tert.-Dodecanethiol / UK informed that TDE is volatile. UK will add to the factscheets the information that IND provided before the meeting. Further work on degradation will be initiated. UK will send this information immediately after the meeting / Disccussion for the March 08 meeting.
99 / UK / 27107-89-7 / 2-Ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]-thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate / See substance 15 and 16.
100 / UK / 31570-04-4 / Tris(2,4-di-tert-butylphenyl)phosphite / A fish dietary study will now be conducted according to a strategy agreed with the UK rapporteur. The results are planned to be used as an additional piece for the “weight of evidence” for assessing bioaccumulation. The protocol will be made available to MS for comments, The lab could start now and finalised by early January '08. / To be discussed at next meeting.
103 / UK / 84852-14-2 / 2,4-Dinonylphenol, branched / See substance no 71
The Polish industry produces below 1000 tons but UK needs a written declaration.
CEFIC is asked to help with this question because the substance is meeting the screening criteria but the Polish IND declares that the substance is not HPVC. DE will contact the industry. UK asked IND to get informed on the RRM put in place. / Progress to be presented next meeting
108 / NO / 77-47-4 / Hexachlorocyclopentadiene / Substance is a mixture.
3/05/07: NO concludes that the substance contains impurities (Conc. > 0.1%) with PBT properties. IND has stop importing the substance in EU.
20/11/07: The factsheet was updated with a sentence proposed by ECB. The concentration of PBT impurities changes depending on the process. CEFIC:PBT impurities is below the 0.1%. / Next meeting
111 / FIN / 64742-04-7 / Extracts (petroleum) heavy paraffin distillate solvent / Substance contains 5 % PAH.
For the pitch RA NL has collected data for 16 EPA PAHs, based on this NL, FIN and Ind to prepare a proposal for the discussion at the next. Within the preparation for REACH IND is also doing work for the larger alkylated PAHs in terms of PBT assessment.
3/05/2007 Not discussed at the meeting.
20/11/2007: No new factsheet available.
After a short discussion about the substance containing impurities meeting PBT criteria it was concluded that with the information provided it was not possible to make a decision. / To be further evaluated under REACH.
113 / UK / 96-69-5 / 4,4'-Thio-bis(2-t-butyl-5-methylphenol) / Ind to confirm that it is a LPV. To park until the conformation will receive.
3/05/2007 Not discussed at the meeting.
20/11/07: IND to confirm that the substance is LPVC. / Before next meeting
117 / UK / 119-47-1 / 6,6'-Di-tert-butyl-2,2'-methylenedi-p-cresol / 20/11/07: UK propose de-selection on the basis not B not P.
The PBT WG meeting agrees. / De-selected
118 / DE / 61789-79-5 / Amines, bis(hydrogenated tallow alkyl) / Substance is based on pre-test provisionally de-listed. BCF < 1200. For final conformation that substance is not B waiting for the GLP
20/11/2007: IND has conducted a test on bioaccumulation and needs to submit the results by end December 2007.
See with substance n. 93 / Next meeting to discuss the report.
124 / FIN/UK / 541-02-6 / Decamethylcyclopentasiloxan
Screening: PBT &vPvB / 03/05/07: Important to include monitoring from water depth, evaporation depends on water depth, dissipation to air is not very high, data from sediments, biota and invertebrates important to understand the distribution in the environment. The approach proposed is very interesting. UK propose further testing. MS to bring comments to TCNES in June07.
20/11/2007: New monitoring data was provided by IND and Norway. FIN will update the factsheets and UK will send a report and invite MS to a Workshop on D4, D5 and D6 where both monitoring and modelling will be addressed. / Further discussion at the next meeting
125 / SE / 38640-62-9 / DIPN / IND informed that they need time to come to reasonable conclusion on biodegradation.
20/11/07: no news from IND;
CEFIC will find out which new information on degradation is available.
The substance contains 7 isomers, some of them are B and T and more information on persistence and the composition is necessary. / Further discussion at the next meeting
ANNEX II