Date: Jan 13, 2009
Environmental NGOs have issued a "SIN" ("Substitute It Now") list of some 220 substances that they would like to see added to the Candidate list of Substances of Very High Concern ("SVHCs") under REACH and ultimately banned under the Authorisation process. Others have floated much longer lists of as many as 1500 substances. EU article producers and importers have been sending these lists to suppliers in an effort to anticipate which substances in their articles may become subject to Article 33 communication obligations under REACH. Yet, to-date, the European Chemical Agency ("ECHA") has added only 15 substances to the Candidate list, see http://echa.europa.eu/chem_data/candidate_list_table_en.asp, and only an additional 7 substances are listed in the current Registry of Intentions by Member States for dossier development as potential SVHCs, see http://echa.europa.eu/chem_data/reg_int_tables/reg_int_curr_int_en.asp. ECHA and the Member State selection of substances of interest to-date may seem puzzling to the casual observer.
Article 58(3) of REACH sets out the priorities for SVHC selection. That Article provides:
Prior to a decision to include substances in Annex XIV, the
Agency shall, taking into account the opinion of the Member State
Committee, recommend priority substances to be included specifying
for each substance the items set out in paragraph 1. Priority shall
normally be given to substances with: (a) PBT or vPvB properties; or (b) wide dispersive use; or (c) high volumes.
The number of substances included in Annex XIV and the dates
specified under paragraph 1 shall also take account of the Agency's
capacity to handle applications in the time provided for. The Agency
shall make its first recommendation of priority substances to be included
in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.
Accordingly, the priorities are set by REACH as substances with persistent, bioaccumulative and Toxic ("PBT") or very persistent and very bioaccumulative ("vPvB") properties; or wide dispersive use; or high volumes. As carcinogens, mutagens, and reproductive toxicants ("CMRs") are banned from consumer use in the EU above the level of 0.1%, it is not likely that many category 1 or 2 CMRs would be a priority for "wide dispersive use." CMRs certainly would be potentially of high priority, if manufactured or imported in the EU in high volumes, but such substances are already subject to extensive controls and probably of lower interest at least for the first wave of SVHC selection.
The initial focus of attention by the Authorities appears to be on PBT/ vPvB substances. Indeed, 5 of the 15 substances on the Candidate list are PBTs/ vPvBs. The other 10 are CMRs but these are the widely discussed phthalates, arsenical compounds, and certain other CMRs that have long been the focus of EU attention.
What other potential PBTs/vPvBs are under investigation? There is a remarkable overlap between the PBT assessments of the former PBT Expert Working Group of the Technical Committee of New and Existing Chemicals, reported at http://ecb.jrc.ec.europa.eu/esis/index.php?PGM=pbt , and the substances either already added to the Candidate list on PBT/ vPvB properties or listed in the ECHA Registry of Intentions.
There are an additional two dozen substances listed on the ECB site as "under evaluation" by a Member State. These substances are:
204-279-1; 118-82-1; 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol: Austria - under evaluation
239-622-4; 15571-58-1; 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate : United Kingdom - under evaluation
248-227-6; 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: United Kingdom - under evaluation
201-329-4; 81-15-2; 5-tert-butyl-2,4,6-trinitro-m-xylene: Netherlands - under evaluation
256-798-8; 50849-47-3; 5-nonylsalicylaldehyde oxime :Netherlands - under evaluation
287-477-0; 85535-85-9; Alkanes, C14-17, chloro : United Kingdom - under evaluation
270-485-3; 68442-68-2; Benzenamine, N-phenyl-, styrenated: Spain - under evaluation
294-232-1; 91696-73-0; Benzenesulfonic acid, C14-44 branched and linear alkyl derives. calcium salts: France -- under evaluation
281-018-8; 83846-43-9; Benzoic acid, 2hydroxy-, mono-C>13-alkyl derivs., calcium salts (2:1) : France - under evaluation
254-052-6 ; 38640-62-9; Bis(isopropyl)naphthalene: Sweden - under evaluation
214-604-9; 1163-19-5; Bis(pentabromophenyl) ether: United Kingdom -- under evaluation
208-764-9; 541-02-6; Decamethylcyclopentasiloxan: Finland/United Kingdom - under evaluation
250-702-8; 31565-23-8; Di(tertdodecyl)pentasulphide: United Kingdom - under evaluation
222-583-2; 3542-36-7; Dichlorodioctylstannane: United Kingdom - under evaluation
265-103-7; 64742-04-7; Extracts (petroleum) heavy paraffin distillate solvent : Finland-- under evaluation
284-578-1; 84929-98-6 ; Magnesium, bis(2hydroxybenzoato-O1,O2)-, ar,ar'-di-C>13-alkyl derivs.: France - under evaluation
209-136-7; 556-67-2; Octamethylcyclotetrasiloxane: Finland - under evaluation
262-975-0; 61788-44-1; Phenol, styrenated: United Kingdom - under evaluation
247-477-3; 26140-60-3; Terphenyl: Finland --under evaluation
262-967-7; 61788-32-7; Terphenyl, hydrogenated: Finland - under evaluation
246-619-1; 25103-58-6; Tert.dodecanethiol: United Kingdom - under evaluation
215-960-8; 1461-25-2; Tetrabutyltin: Netherlands - under evaluation
222-733-7;3590-84-9 ;Tetraoctyltin: Netherlands - under evaluation
250-709-6 31570-04-4 Tris(2,4 di-tert-butylphenyl)phosphate: United Kingdom - under evaluation
Member State interest in at least many of these substances appears to be active as the Commission as recently as 28 March 2008 issued a Regulation (465/2008) to call in environmental fate and effects data for 16 of the above-listed substances.
Certainly, the mere fact these substances are under evaluation as potential PBTs/vPvBs does not mean that they will be determined to be as such, or added to the Candidate list, or become subject to Authorisation. However, companies with an interest in these substances would be well advised to take appropriate action to ensure that these substances are evaluated fairly and consistent with the best available science.