Ares(2020)250320

COMMISSION REGULATION (EU) …/…

of XXX

amending Annex III to Regulation (EC) 1107/2009 of the European Parliament and of the Council listing co-formulants which are not accepted for inclusion in plant protection products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC 1 , and in particular Article 27(2) and Article 78(2) thereof,

Whereas:

(1)Co-formulants are described in Article 2(3)(c) of Regulation (EC) No 1107/2009 as substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners nor synergists.

(2)Co-formulants are unacceptable in plant protection products if their residues, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or on groundwater or an unacceptable effect on the environment. Co-formulants are also unacceptable in plant protection products if their use, consequent on application consistent with good plant protection practice, and having regard to realistic conditions of use, have a harmful effect on human or animal health or have an unacceptable effect on plants, plant protection products or the environment. Such unacceptable co‑formulants are to be listed in Annex III to Regulation (EC) No 1107/2009.

(3)Co-formulants are substances or preparations used together with active substances in plant protection products and are thus equally spread in the environment. Therefore, the criteria concerning human health, the environment, ecotoxicity and groundwater, provided for by points 3.6, 3.7, 3.8 and 3.10 of Annex II to Regulation (EC) No 1107/2009, should also be relevant to identify unacceptable co-formulants.

(4)The list of unacceptable co-formulants thus should include substances with a harmonised classification as carcinogens, category 1A or 1B, as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in accordance with Annex VI to Regulation (EC) No 1272/2008 2 .

(5)The list of unacceptable co-formulants should further include substances identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with points (d) and (e) of Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council 3 .

(6)The list of unacceptable co-formulants should also include substances of very high concern due to endocrine disrupting properties in accordance with point (f) of Article 57 of Regulation (EC) No 1907/2006 or substances identified as endocrine disruptors under Regulation (EC) No 528/2012 4 concerning the making available on the market and use of biocidal products or substances identified as persistent organic pollutants (POP) under Regulation (EC) No 850/2004 5 .

(7)Regulation (EC) No 1907/2006 sets out restrictions for certain dangerous substances in its Annex XVII. Where the use of those substances is subject to restrictions as co‑formulants in plant protection products, they should be added to that list of co‑formulants in Annex III to Regulation (EC) No 1107/2009.

(8)Member States have identified unacceptable co-formulants for plant protection products under Council Directive 91/414/EEC 6 and under Article 81 of Regulation (EC) No 1107/2009. Such co-formulants have been notified by Austria, Belgium, France, Germany, Italy, Lithuania, Spain and Norway. Amongst those co-formulants, those with a harmonised classification as carcinogens, category 1A or 1B, as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in accordance with Annex VI to Regulation (EC) No 1272/2008, those identified as PBT or vPvB according to points (d) and (e) of Article 57 of Regulation (EC) No 1907/2006, those identified as substances of very high concern due to endocrine disrupting properties in accordance with point (f) of Article 57 of Regulation (EC) No 1907/2006, and those identified as POP under Regulation (EC) No 850/2004 should be listed in Annex III to Regulation (EC) No 1107/2009.

(9)The use of POE tallowamines (CAS No 61791-26-2) in plant protection products containing glyphosate was prohibited by Commission Implementing Regulation (EU) 2016/1313 7 , as concerns were identified in relation to the toxicity of POE tallowamines and their potential to negatively affect human health. Given that those concerns are due to the intrinsic properties of the substances concerned and are thus not limited to formulated products containing glyphosate but are equally valid for formulated products containing other active substances, POE tallowamines should also be added to that list of co-formulants in Annex III to Regulation (EC) No 1107/2009.

(10)The use of PHMB (1600; 1.8), CAS number 27083-27-8 and 32289-58-0, and PHMB (1415; 4.7), CAS number 32289-58-0 and 1802181-67-4, as in-can preservatives in plant protection products would lead to unacceptable effects on human health and in the environment. Commission Implementing Decisions (EU) 2016/109 8 and 2018/619 9 did not approve them as existing active substances for use in biocidal products for product-type 6 (in-can preservatives), amongst other product types due to unacceptable risks for human health and the environment. Therefore PHMB (1600; 1.8) and PHMB (1415; 4.7) should also be added to Annex III to Regulation (EC) No 1107/2009.

(11)Co-formulants to be listed in Annex III to Regulation (EC) No 1107/2009 may also be contained in adjuvants placed on the market. As detailed rules for the authorisation of adjuvants, in accordance with Article 58(2) of Regulation (EC) No 1107/2009, have not yet been established, Member States may continue to apply national provisions as regards adjuvants in accordance with Article 81(3) of that Regulation. As Regulation (EC) No 1107/2009 aims to prevent the placing on the market or use of adjuvants containing prohibited co-formulants, it is necessary to ensure that also adjuvants, to be mixed with plant protection products, do not contain any of those unacceptable co‑formulants.

(12)Member States should be provided with sufficient time to review the composition of the plant protection products and adjuvants currently authorised in their territory, in order to assess whether they contain co-formulants listed in Annex III to Regulation (EC) No 1107/2009 and to withdraw or amend authorisations for plant protection products and adjuvants containing those co‑formulants.

(13)For plant protection products or adjuvants containing a co-formulant listed in Annex III to Regulation (EC) No 1107/2009, where Member States grant any grace period in accordance with Article 46 of that Regulation or in accordance with national provisions for authorisation of adjuvants, respectively, that period should expire for the sale and distribution at the latest 3 months and for the disposal, storage and use additional 9 months after the amendment or withdrawal of the authorisations.

(14)Co-formulants to be listed in Annex III to Regulation (EC) No 1107/2009 may be present as unintentional impurities in other co-formulants, which as such are acceptable for use in plant protection products or adjuvants. Therefore, the individual concentration of the unacceptable co-formulants in the finished plant protection product or adjuvant should be less than 0,01 % weight by weight (w/w) in order to be considered as acceptable unintentional impurity, unless a different limit is provided due to technical limitations of relevant analytical methods.

(15)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this Regulation.

Article 2

Member States which have granted authorisations for plant protection products containing co‑formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation, shall amend or withdraw those authorisations as soon as possible but no later than [Office of Publications please insert date corresponding to 2 years from the date of the Entry into Force].

Article 3

Member States shall not authorise the placing on the market or use of adjuvants containing co‑formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation.

Member States which have authorised adjuvants containing co-formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation, shall amend or withdraw those authorisations as soon as possible and no later than [Office of Publications please insert date corresponding to 2 years from the date of the Entry into Force].

Article 4

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 or national provisions for authorisation of adjuvants shall be as short as possible and shall expire for sale and distribution at the latest 3 months and for disposal, storage and use additional 9 months after the date of withdrawal or amendment of the authorisation referred to in Articles 2 and 3.

Article 5

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Commission

The President
Ursula VON DER LEYEN

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ANNEX

Annex III to Regulation (EC) No 1107/2009 is replaced by the following:

ʽANNEX III

List of co-formulants which are not accepted for inclusion in plant protection products as referred to in Article 27 1

No.	Name	EC names/Other names	CAS number	EC number	Classification/Other properties
1.	1-Chloro-2,3-epoxypropane	Epychloridrine, 2,3-Epoxypropyl chloride	106-89-8	203-439-8	Carcinogenic cat.1B
2.	1, 2- Dichloroethane	Ethane, 1,2-dichloro	107-06-2	203-458-1	Carcinogenic cat.1B
3.	1-Ethylpyrrolidin-2-one	N-ethyl-2-pyrrolidone	2687-91-4	220-250-6	Reproductive toxicity cat.1B
4.	2-Ethoxyethanol	Ethanol, 2-ethoxy	110-80-5	203-458-1	Reproductive toxicity cat.1B
5.	2-Ethoxyethanol acetate	Ethanol, 2-ethoxy-, 1-acetate	111-15-9	203-839-2	Reproductive toxicity cat.1B
6.	1-Methyl-2-pyrrolidone	2,pyrrolidinone, 1-methyl	872-50-4	212-828-1	Reproductive toxicity cat.1B
7.	2-Methoxyethanol	Ethanol, 2-methoxy	109-86-4	203-713-7	Reproductive toxicity cat.1B
8.	2-Methoxyethanol acetate	Ethanol, 2-methoxy-, 1-acetate	110-49-6	203-772-9	Reproductive toxicity cat.1B
9.	2-Methoxypropanol	1-Propanol, 2-methoxy	1589-47-5	216-455-5	Reproductive toxicity cat.1B
10.	2-Nitropropane	Propane, 2-nitro	79-46-9	201-209-1	Carcinogenic cat.1B
11.	4-Nonylphenol, branched, ethoxylated	Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy-, branched	127087-87-0	500-315-8	Endocrine disrupting properties (REACH Article 57(f) - Environment)
12.	2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol	Ethanol, 2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]-	7311-27-5	230-770-5	Endocrine disrupting properties (REACH Article 57(f) – Environment)
13.	2-[2-(4-nonylphenoxy)ethoxy]ethanol	Ethanol, 2-[2-(4-nonylphenoxy)ethoxy]-	20427-84-3	243-816-4	Endocrine disrupting properties (REACH Article 57(f) – Environment)
14.	4-Nonylphenol, ethoxylated	Poly(oxy-1,2-ethanediyl), α-(4-nonylphenyl)-ω-hydroxy-	26027-38-3	500-045-0	Endocrine disrupting properties (REACH Article 57(f) – Environment)
15.	20-(4-nonylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol	3,6,9,12,15,18-Hexaoxaeicosan-1-ol, 20-(4-nonylphenoxy)-	27942-27-4	248-743-1	Endocrine disrupting properties (REACH Article 57(f) – Environment)
16.	2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol	Ethanol, 2-(4-nonylphenoxy)-	104-35-8		Endocrine disrupting properties (REACH Article 57(f) – Environment)
17.	2-[2-(4-nonylphenoxy)ethoxy]ethanol	3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol, 26-(4-nonylphenoxy)-	14409-72-4		Endocrine disrupting properties (REACH Article 57(f) – Environment)
18.	4-Nonylphenol, ethoxylated	3,6,9,12,15-Pentaoxaheptadecan-1-ol, 17-(4-nonylphenoxy)-	34166-38-6		Endocrine disrupting properties (REACH Article 57(f) – Environment)
19.	20-(4-nonylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol	Poly(oxy-1,2-ethanediyl), α-(isononylphenyl)-ω-hydroxy-	37205-87-1		Endocrine disrupting properties (REACH Article 57(f) – Environment)
20.	4-Nonylphenol, branched, ethoxylated	Ethanol, 2-[2-(4-tert-nonylphenoxy)ethoxy]-	156609-10-8		Endocrine disrupting properties (REACH Article 57(f) – Environment)
21.	2-(2-[4-(1,1,3,3-Tetramethylbutyl)phenoxy]ethoxy)ethanol	Ethoxylated octylphenol Polyethylene Glycol Octylphenyl Ether Poly(oxy-1,2-ethanediyl), α-[(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy-	9036-19-5	618-541-1	Endocrine disrupting properties (REACH Article 57(f) – Environment)
22.	Acrylamide	2-propenamide	79-06-1	201-173-7	Carcinogenic cat.1B / Mutagenic cat.1B
23.	Alkylarylpolyglycol ether		9016-45-9	934-221-7	Endocrine disrupting properties (REACH Article 57(f) - ENV)
24.	Aluminium silicate containing > 0.1 % particles of crystalline silica with diameter below 50 um) 2	Kaolin	1332-58-7	310-194-1
25.	Amines, tallow alkyl, ethoxylated (POE-tallowamine)	Amines, tallow alkyl, ethoxylated	61791-26-2	500-153-8	Concerns or data gaps related to potential effects on human health or the environment
26.	Amines, tallow alkyl, ethoxylated propoxylated (POEP-tallowamine)	Amines, tallow alkyl, ethoxylated propoxylated	68213-26-3	614-378-5	Concerns or data gaps related to potential effects on human health or the environment
27.	Asbestos fibres - Actinolite	Actinolite asbestos	77536-66-4	616-471-6	Carcinogenic cat.1A
28.	Asbestos fibres - Amosite	Amiosite asbestos	12172-73-5	601-801-3	Carcinogenic cat.1A
29.	Asbestos fibres - Anthophyllite	Antophyllite asbestos	77536-67-5		Carcinogenic cat.1A
30.	Asbestos fibres - Chrysotile	Chrysotile asbestos	12001-29-5 132207-32-0-		Carcinogenic cat.1A
31.	Asbestos fibres - Crocidolite	Crocidolite asbestos	12001-28-4		Carcinogenic cat.1A
32.	Asbestos - Tremolite	Tremolite asbestos	77536-68-6		Carcinogenic cat.1A
33.	Attapulgite	Palaygorskite	12174-11-7		Carcinogenic cat.1A
34.	Benzene	Benzole	71-43-2	200-753-7	Carcinogenic cat.1A / Mutagenic cat.1B
35.	Benzo[def]chrysene	Benzo [a] pyrene	50-32-8	200-028-5	Carcinogenic cat.1B
36.	Boric acid	Boric acid	10043-35-3	233-139-2	Reproductive toxicity cat.1B
37.	Buta-1,3-diene	1,3-butadiene	106-99-0	203-450-8	Carcinogenic cat.1A / Mutagenic cat.1B
38.	Butane (containing ≥ 0,1 % butadiene (CAS No. 203-450-8)	Butane	106-97-8	203-448-7	Carcinogenic cat.1A
39.	Cristobalite (SiO2)		14464-46-1	238-455-4	See Silicium dioxide
40.	Dibutyl phthalate	n-Butyl phthalate	84-74-2	201-557-4	Endocrine disrupting properties (REACH Article 57(f) – Human Health) Reproductive toxicity cat.1B
41.	Diisobutyl phthalate	bis(2-methylpropyl) benzene-1,2-dicarboxylate	84-69-5	201-553-2	Endocrine disrupting properties (REACH Article 57(f) – Human Health) Reproductive toxicity cat.1B
42.	Disodium octaborate	Disodium octaborate anhydrous	12008-41-2	234-541-0	Reproductive toxicity cat.1B
43.	Disodium; boron; oxygen(2-); tetrahydrate	Boric acid,disodiumsalt,tetrahydrate	12280-03-4	234-541-0	Reproductive toxicity cat.1B
44.	Disodium tetraborate, anhydrous	Boron sodium oxide	1330-43-4	215-540-4	Reproductive toxicity cat.1B
45.	Disodium tetraborate, decahydrate	Borax	1303-96-4	215-540-4	Reproductive toxicity cat.1B
46.	Disodium tetraborate, pentahydrate	Boron sodium oxide, hydrated	12179-04-3	215-540-4	Reproductive toxicity cat.1B
47.	Distillates (petroleum), hydrotreated heavy naphthenic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64742-52-5	265-155-0	Carcinogenic cat.1B
48.	Distillates (petroleum), hydrotreated heavy paraffinic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64742-54-7	265-157-1	Carcinogenic cat.1B
49.	Distillates (petroleum), hydrotreated light naphthenic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64742-53-6	265-156-6	Carcinogenic cat.1B
50.	Distillates (petroleum), hydrotreated light paraffinic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64742-55-8	265-158-7	Carcinogenic cat.1B
51.	Distillates (petroleum), solvent-dewaxed heavy paraffinic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64742-65-0	265-169-7	Carcinogenic cat.1B
52.	Distillates (petroleum), solvent-refined heavy paraffinic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64741-88-4	265-090-8	Carcinogenic cat.1B
53.	Distillates (petroleum), solvent-refined light paraffinic with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		64741-89-5	265-091-3	Carcinogenic cat.1B
54.	Ethylene oxide	Oxyrane, Epoxyethane	75-21-8	200-849-9	Carcinogenic cat.1B
55.	Formaldehyde	Formalin, Methanal,Formol	50-00-0	200-001-8	Carcinogenic cat.1B
56.	Formamide	Methanamide	75-12-7	200-842-0	Reproductive toxicity cat.1B
57.	Isobutane (containing ≥ 0,1 % butadiene (CAS No. 203-450-8)	Propane, 2-methyl	75-28-5	200-857-2	Carcinogenic cat.1A / Mutagenic cat. 1B
58.	Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		72623-86-0	276-737-9	Carcinogenic cat.1B
59.	Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		101316-70-5	309-875-6	Carcinogenic cat.1B
60.	Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		72623-87-1	276-738-4	Carcinogenic cat.1B
61.	Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity with a content of ≥ 3.0 % DMSO-extract (measured by IP 346)		72623-85-9	276-736-3	Carcinogenic cat.1B
62.	N, N-dimethylformamide	Dimethyl formamide, DMF	68-12-2	200-679-5	Reproductive toxicity cat.1B
63.	Naphtha (petroleum), heavy alkylate predominantly branched chain C9-C12 with a content of ≥ 0.1 % benzene (CAS No. 200‑753-7)		64741-65-7	265-067-2	Carcinogenic cat.1B / Mutagenic cat.1B
64.	Naphtha (petroleum), hydrodesulfurized heavy predominantly C7-C12 with a content of ≥ 0.1 % benzene (CAS No. 200-753-7)		64742-82-1	265-185-4	Carcinogenic cat.1A/ Mutagenic cat.1B
65.	Naphtha (petroleum), hydrodesulfurized light, dearomatized predominantly C7 paraffins and cycloparaffins with a content of ≥ 0.1 % benzene (CAS No. 200-753-7)		92045-53-9	295-434-2	Carcinogenic cat.1A / Mutagenic cat.1B
66.	Naphtha (petroleum), hydrotreated heavy predominantly C6-C13 with a content of ≥ 0.1 % benzene (CAS No. 200-753-7)		64742-48-9	265-150-3	Carcinogenic cat.1A / Mutagenic cat.1B
67.	Naphta (petroleum), light arom. predominantly C8-C10 with a content of ≥ 0.1% benzene (CAS N. 200-753-7)		64742-95-6	265-199-0	Carcinogenic cat.1A / Mutagenic cat.1B
68.	Nitrobenzene	Benzene, nitro	98-95-3	202-716-0	Reproductive toxicity cat.1B/ Carcinogenic cat. 2
69.	N-methylformamide	Formamide, N-methyl-	123-39-7	204-624-6	Reproductive toxicity cat.1B
70.	Nonyl phenol, ethoxylated	2-[2-(4-nonylphenoxy)ethoxy]ethanol	9016-45-9	500-024-6	Endocrine disrupting properties (REACH Article 57(f) - Environment)
71.	Phenol, 4-isononyl-	p-isononylphenol	26543-97-5	247-770-6	Endocrine disrupting properties (REACH Article 57(f) – Environment)
72.	Phenol, 4-nonyl-	p-nonylphenol	104-40-5	203-199-4	Endocrine disrupting properties (REACH Article 57(f) – Environment)
73.	Phenol, 4-nonyl-, branched	Phenol, 4-nonyl-, branched	84852-15-3	284-325-5	Endocrine disrupting properties (REACH Article 57(f) – Environment)
74.	Phenol, nonyl-	Nonylphenol	25154-52-3	246-672-0	Endocrine disrupting properties (REACH Article 57(f) – Environment)
75.	Phenol, nonyl-, branched	Phenol, nonyl-, branched	90481-04-2	291-844-0	Endocrine disrupting properties (REACH Article 57(f) – Environment)
76.	Phenol, 4-(1,1-dimethylheptyl)-	p-(1,1-dimethylheptyl)phenol	30784-30-6	250-339-5	Endocrine disrupting properties (REACH Article 57(f) – Environment)
77.	Phenol, 4-(1-ethyl-1,3-dimethylpentyl)-	4-(1-Ethyl-1,3-dimethylpentyl)phenol	186825-36-5	-	Endocrine disrupting properties (REACH Article 57(f) – Environment)
78.	Phenol, 4-(1-ethyl-1,4-dimethylpentyl)-	4-(1-Ethyl-1,4-dimethylpentyl)phenol	142731-63-3	-	Endocrine disrupting properties (REACH Article 57(f) – Environment)
79.	Phenol, 4-(1-ethyl-1-methylhexyl)-	4-(1-ethyl-1-methylhexyl)phenol	52427-13-1	257-907-1	Endocrine disrupting properties (REACH Article 57(f) – Environment)
80.	Phenol, 4-(1-methyloctyl)-	p-(1-methyloctyl)phenol	17404-66-9	241-427-4	Endocrine disrupting properties (REACH Article 57(f) – Environment)
81.	Octyl phenol ethoxylated	Octoxynol	9002-93-1		Endocrine disrupting properties (REACH Article 57(f) – Environment)
82.	Orthoboric acid, sodium salt	Boric acid, sodium salt	7311-27-5	237-560-2	Reproductive toxicity cat.1B
83.	Pyridine, alkyl derivatives, with a content of ≥ 0.1 % benzene (CAS No. 200-753-7)		68391-11-7	269-929-9	Carcinogenic cat.1A / Mutagenic cat.1B
84.	PHMB CoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride),(iminoimidocarbonyl, hexamethylene hydrochloride	Guanidine, N,N'''-1,6-hexanediylbis[N'-cyano-, polymer with 1,6-hexanediamine, hydrochloride Poly[iminocarbonimidoyliminocarbonimidoylimino-1,6-hexanediyl], hydrochloride Cyanamide, N-cyano-, compd. with 1,6-hexanediamine (2:1), polymer with 1,6-hexanediamine hydrochloride (1:2)	27083-27-8 and 32289-58-0 and 1802181-67-4		Not approved for use in biocidal products for product-type 6 (in-can preservatives).
85.	Quinoline	Quinoline	91-22-5	202-051-6	Carcinogenic cat.1B
86.	Quartz sand (containing > 0.1 % particles with diameter below 50 um) 3	Quartz, Silicium dioxide, Silica, Silicon dioxide, SiO2	14808-60-7	238-878-4
87.	Silicium dioxide containing > 0.1 % particles with diameter below 50 um) 4	Kieselguhr	61790-53-2	310-127-6
88.	Tetraboron disodium heptaoxide, hydrate	Boron sodium oxide, hydrate	12267-73-1	235-541-3	Reproductive toxicity cat.1B
89.	Tetrahydrofurfuryl Alcohol	2-Furanmethanol-tetraydro	97-99-4	202-625-6	Reproductive toxicity cat.1B
90.	Trydimite (SiO2)		15468-32-3	239-487-1	See Silicium dioxide

ʼ.

(1) The limit for the acceptable presence of the substances listed in the table as unintentional impurity is 0,01 % (weight by weight (w/w)) except where stated otherwise in this Annex.

(2) The limit for the acceptable presence as unintentional impurity is 0,5 % (weight by weight (w/w)).

(3) The limit for the acceptable presence as unintentional impurity is 0,5 % (weight by weight (w/w)).

(4) The limit for the acceptable presence as unintentional impurity is 0,5 % (weight by weight (w/w)).

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