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Document 02014R1062-20220619
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)Text with EEA relevance
Consolidated text: Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)Text with EEA relevance
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)Text with EEA relevance
02014R1062 — EN — 19.06.2022 — 004.001
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COMMISSION DELEGATED REGULATION (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294 10.10.2014, p. 1) |
Amended by:
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Official Journal |
||
No |
page |
date |
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COMMISSION DELEGATED REGULATION (EU) 2017/698 of 3 February 2017 |
L 103 |
1 |
19.4.2017 |
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COMMISSION DELEGATED REGULATION (EU) 2019/157 of 6 November 2018 |
L 31 |
1 |
1.2.2019 |
|
COMMISSION DELEGATED REGULATION (EU) 2019/227 of 28 November 2018 |
L 37 |
1 |
8.2.2019 |
|
COMMISSION DELEGATED REGULATION (EU) 2022/825 of 17 March 2022 |
L 147 |
3 |
30.5.2022 |
Corrected by:
COMMISSION DELEGATED REGULATION (EU) No 1062/2014
of 4 August 2014
on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council
(Text with EEA relevance)
CHAPTER 1
SUBJECT MATTER AND DEFINITIONS
Article 1
Subject matter
This Regulation lays down rules for the carrying out of the work programme for the systematic examination of all existing active substances referred to in Article 89 of Regulation (EU) No 528/2012.
Article 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘non-approval decision’ means a decision not to approve a substance/product-type combination pursuant to Article 9(1)(b) of Regulation (EU) No 528/2012 or to the third subparagraph of Article 89(1) of that Regulation, or not to include it in Annex I or IA to Directive 98/8/EC;
‘substance/product-type combination included in the review programme’ means a substance/product-type combination listed in Annex II which complies with the following conditions:
it has not been the subject of either of the following:
it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has been repealed;
‘participant’ means a person who has submitted an application for a substance/product-type combination included in the review programme, or has submitted a notification found compliant pursuant to Article 17(5) of this Regulation, or on whose behalf such application or notification has been submitted.
‘evaluating competent authority’ means the competent authority designated pursuant to Article 81 of Regulation (EU) No 528/2012 of the Member State indicated in Annex II to this Regulation.
CHAPTER 2
PROCESS FOR EVALUATION OF DOSSIERS
Article 3
Application for approval or inclusion in Annex I to Regulation (EU) No 528/2012
Where the application concerns inclusion in Annex I to Regulation (EU) No 528/2012, it may only concern category 1, 2, 3, 4, 5 or 6 of that Annex.
Article 4
Acceptance of applications
Article 5
Validation of applications for approval or inclusion in category 6 of Annex I to Regulation (EU) No 528/2012
The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 2.
The evaluating competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant and the Agency accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) of Regulation (EU) No 528/2012 shall be reimbursed.
On validating an application, the evaluating competent authority shall without delay inform the participant, the Agency and other competent authorities accordingly, indicating the date of the validation.
Article 6
Evaluation of applications
This Article shall apply where any of the following conditions applies:
where an application has been validated pursuant to Article 5;
where the evaluating competent authority has accepted the dossier as complete pursuant to Article 13 of Regulation (EC) No 1451/2007 but not yet submitted the competent authority report to the Commission pursuant to Article 14(4) of that Regulation;
where an application for inclusion in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012 has been accepted by the Agency pursuant to Article 4(2) and the fee has been paid pursuant to Article 4(4).
Where several participants support the same substance/product-type combination, the evaluating competent authority shall draft only one assessment report. The assessment report and the conclusions shall be sent within either of the following time-limits, whichever is the later:
365 days of the last validation referred to in paragraph 1(a), acceptance of completeness referred to in paragraph 1(b) or payment of the fee referred to in paragraph 1(c), for the substance/product-type combination in question;
the time limits provided for by Annex III.
The 365-day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the date the information is received. Unless it is justified by the nature of the data requested or by exceptional circumstances, the suspension shall not exceed the following time-limits:
365 days in cases where the additional information relates to concerns which were not addressed under Directive 98/8/EC or under the practice established for application of that Directive;
180 days in other cases.
Upon finalisation of its hazard evaluation, the evaluating competent authority shall without undue delay and no later than at the time of submission of the assessment report pursuant to paragraph 3, as appropriate:
submit a proposal to the Agency pursuant to Article 37(1) of Regulation (EC) No 1272/2008, where it considers that one of the criteria referred to in Article 36(1) thereof is fulfilled and not properly addressed in part 3 of Annex VI to that Regulation;
consult the Agency where it considers that one of the criteria of Article 5(1)(d) or (e) of Regulation (EU) No 528/2012, or the condition of Article 10(1)(d) of that Regulation, is fulfilled and not properly addressed in Annex XIV to Regulation (EC) No 1907/2006 or in the candidate list referred to in Article 59(1) of that Regulation.
Article 6a
Applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019
By derogation from the time limits laid down in Article 6(3), the assessment report and the conclusions shall be sent by the evaluating competent authority within either of the following time limits, whichever is the later:
31 December 2020;
the time limit for submitting the assessment report pursuant to Article 6(3)(b) set out in Annex III.
Article 7
Opinion of the Agency
This Article shall apply where either of the following conditions applies:
where the evaluating competent authority has submitted an assessment report pursuant to Article 6(2) and, where relevant, a proposal or a consultation pursuant to Article 6(7);
where a competent authority report has been submitted to the Commission pursuant to Article 14(4) of Regulation (EC) No 1451/2007, but the assessment report has not yet been reviewed within the Standing Committee on Biocidal Products pursuant to Article 15(4) of that Regulation.
The Agency shall start the preparation of the opinion within either of the following deadlines, whichever is the later:
three months of the acceptance of the report;
the time limits provided for by Annex III.
The Agency shall submit the opinion to the Commission within 270 days of the start of the preparation.
Article 8
Active substances which are candidates for substitution
Article 9
Commission decision
Upon receipt of the opinion of the Agency pursuant to Article 7(2), the Commission shall without undue delay prepare a draft decision for adoption pursuant to Article 89(1) or, as appropriate, Article 28(1) of Regulation (EU) No 528/2012.
CHAPTER 3
CHANGES OF ELEMENTS OF THE REVIEW PROGRAMME
Article 10
Joining or replacing participants by mutual agreement
Article 11
Participants' withdrawal
A participant shall be considered to have withdrawn its support for a substance/product-type combination in the review programme in the following cases:
where it has informed the Agency or the evaluating competent authority through the Register of its intention to withdraw;
where it has failed to submit an application within the time limits specified in Article 3(2);
where its application has been rejected pursuant to Article 4(1), Article 4(4) or Article 5(4);
where it has failed to provide the additional information within the time limits provided for by Article 6(5);
where it has otherwise failed to pay the fees payable to the evaluating competent authority or the Agency.
Article 12
Consequences of a timely withdrawal
Article 13
Redefinition of active substances
Article 14
Taking over the role of participant
The Agency shall publish an open invitation to take over the role of participant for a substance/product-type combination where one of the following cases applies:
where all participants supporting the same substance/product-type combination have made a timely withdrawal pursuant to Article 11, and the role of participant for that combination has not previously been taken over;
following a redefinition pursuant to Article 13, in which case, the invitation shall only concern any substance covered by the existing identity in Annex II, but not by the new substance identity.
▼M1 —————
Article 15
Substance/product-type combinations eligible for inclusion in the review programme
Where a biocidal product covered by the scope of Regulation (EU) No 528/2012 and being placed on the market consists of, contains or generates an existing active substance which is neither approved, nor included in the review programme, for the product-type, and is not included in Annex I to that Regulation, that substance shall be eligible for inclusion in the review programme for the relevant product-type on any of the following grounds:
the person placing the product on the market has relied on guidance published by, or written advice received from, the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or Article 81 of Regulation (EU) No 528/2012, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Commission;
the substance has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007;
the biocidal product belongs under Regulation (EU) No 528/2012 to a different product-type than the one it belonged to under Directive 98/8/EC, as a result of a modification of scope of those product-types, and contains a substance included in the review programme for the original product-type but not for the new one.
Article 16
Declaration of interest to notify
A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the Register by any person with an interest to notify a substance/product-type combination to one of the following recipients:
to the Commission at the latest 12 months after the publication of the decision or guidance referred to in point (a) of Article 15;
to the Agency at the latest 30 October 2015 in cases referred to in point (b) of Article 15;
to the Commission at the latest 30 October 2015 in cases referred to in point (c) of Article 15.
In cases referred to in points (a) and (c) of Article 15, a substance/product-type combination shall be considered as notified by a participant, and shall not be eligible for additional notification where the following conditions apply:
the relevant active substance is already included in the review programme;
one of the dossiers submitted to the evaluating Member State for the relevant active substance already contains all the data required for the evaluation of the product-type;
the participant which has submitted that dossier indicates an interest to support the substance/product-type combination.
Article 17
Notification procedure
Where a notification has been found compliant pursuant to paragraph 5, the Agency shall without delay:
where the notification has been submitted pursuant to Article 14(2), update the information in the Register with respect to the identity of the participant and, where relevant, of the substance;
where the notification has been submitted pursuant to Article 16(5), inform the Commission of the compliance.
Article 18
Inclusion in the review programme
Where a substance/product-type combination is considered notified in accordance with Article 16(6), or where the Agency informs the Commission of compliance in accordance with Article 17(7)(b), the Commission shall include the substance/ product-type combination in the review programme.
Article 19
Information on substances no longer supported under the review programme
Where no notification has been received within the time limit referred to in Article 16(5), or where a notification referred to in that Article has been received and subsequently rejected by the Agency pursuant to Article 17(4) or (5), the Agency shall inform the Member States thereof through the Register and publish that information electronically.
Article 20
Commission decisions on substances no longer supported under the review programme
The Commission shall prepare a draft non-approval decision pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012 in the following cases:
where the Agency informs the Commission of all participants' timely withdrawal pursuant to Article 12(3) of this Regulation;
where no person has submitted a notification within the time limits provided for by Article 14(2) of this Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or Article 17(5) thereof;
where a notification has been submitted within the time limits provided for by Article 14(2) of this Regulation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification only covers part of the existing identity in Annex II to this Regulation.
In case referred to in point (c) of first paragraph, the draft non-approval decision shall cover any substance covered by the existing identity in Annex II to this Regulation, but not by the notification or any approval decision.
CHAPTER 4
TRANSITIONAL MEASURES
Article 21
Transitional measures for substances referred to in Article 15
A Member State may continue to apply its current system or practice of making available on the market and using a biocidal product consisting of, containing or generating an existing active substance referred to in points (b) and (c) of Article 15. In such cases:
the biocidal product shall no longer be made available on the market with effect from 24 months after the date of entry into force of this Regulation;
the use of existing stocks of the biocidal product may continue until 30 months after the date of entry into force of this Regulation.
A Member State may continue to apply its current system or practice of making available on the market and using a biocidal product consisting of, containing or generating an existing active substance referred to in point (a) of Article 15. In such cases:
The biocidal product shall no longer be made available on the market with effect from 24 months after of either of the following, whichever is the later:
the date of entry into force of this Regulation;
the notification or publication of the decision or guidance referred to in point (a) of Article 15.
Use of existing stocks of the biocidal product may continue until 30 months after either of the following, whichever is the later:
the date of entry into force of this Regulation;
the notification or publication of the decision or guidance referred to in point (a) of Article 15.
A Member State may continue to apply its current system or practice of making available on the market or using a biocidal product consisting of, containing or generating an existing active substance for which the Agency has made a publication pursuant to Article 16(4) for the relevant product-type. In such cases:
The biocidal product shall no longer be made available on the market with effect from 12 months after the date when the Agency has made the electronic publication referred to in Article 19; and
Use of existing stocks of the biocidal product may continue until 18 months after the date of that publication.
Article 22
Essential use
The Member State to which the derogation is granted shall:
ensure that continued use is limited to such cases where and such time during which the conditions of paragraph 1 are fulfilled;
impose appropriate risk mitigation measures to ensure that exposure of humans, animals and the environment is minimised;
ensure that alternatives are being sought, or that an application for approval of the active substance is being prepared for submission in accordance with Article 7 of Regulation (EU) No 528/2012 in due time before the expiry of the derogation.
CHAPTER 5
FINAL PROVISIONS
Article 23
Repeal
Regulation (EC) No 1451/2007 is repealed.
References to that Regulation shall be construed as references to this Regulation.
Article 24
Entry into force
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.
ANNEX I
Information requirements for notifications pursuant to Article 17
A notification pursuant to Article 17 shall contain the following information:
evidence that the substance is an existing active substance within the meaning of Article 3(1)(d) of Regulation (EU) No 528/2012;
an indication of the product-type(s) concerned by the notification;
information on any studies that have been commissioned for the purpose of application for approval or inclusion in Annex I to Regulation (EU) No 528/2012, as well as the expected date of completion;
the information referred to in Sections
1, 2 and 7.1 to 7.5 of the table in Title 1 of Annex II to Regulation (EU) No 528/2012 for chemical substances;
1, 2 and 6.1 to 6.4 of the table in Title 2 of Annex II to Regulation (EU) No 528/2012 for micro-organisms;
where the notification has been made in a case referred to in point (a) of Article 15, evidence that the substance was on the market as an active substance of a biocidal product falling under the relevant product-type on the date of notification or publication of the decision or guidance referred to in that point.
ANNEX II
SUBSTANCE/PRODUCT-TYPE COMBINATIONS INCLUDED IN THE REVIEW PROGRAMME ON 17 MARCH 2022
Active substance/product-type combinations supported on 17 March 2022, excluding any other nanomaterial than that explicitly mentioned in entry 1017 and excluding any generation in situ of the active substance except when explicitly mentioned with the reference to the supported precursor(s)
Entry number |
Substance name |
Rapporteur Member State |
EC number |
CAS number |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
17 |
18 |
19 |
21 |
22 |
1 |
Formaldehyde |
DE |
200-001-8 |
50-00-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
9 |
Bronopol |
ES |
200-143-0 |
52-51-7 |
|
x |
|
|
|
x |
|
|
|
|
x |
x |
|
|
|
|
|
x |
36 |
Ethanol |
EL |
200-578-6 |
64-17-5 |
x |
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37 |
Formic acid |
BE |
200-579-1 |
64-18-6 |
|
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
1025 |
Performic acid generated from formic acid and hydrogen peroxide |
BE |
|
|
|
x |
|
x |
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
43 |
Salicylic acid |
NL |
200-712-3 |
69-72-7 |
|
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52 |
Ethylene oxide |
NO |
200-849-9 |
75-21-8 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
69 |
Glycolic acid |
NL |
201-180-5 |
79-14-1 |
|
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1026 |
Peracetic acid generated from tetraacetylethylenediamine (TAED) and hydrogen peroxide |
AT |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1027 |
Peracetic acid generated from 1,3- diacetyloxypropan-2-yl acetate and hydrogen peroxide |
AT |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71 |
L-(+)-lactic acid |
DE |
201-196-2 |
79-33-4 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
79 |
(2R,6aS,12aS)-1,2,6,6a,12,12a-Hexahydro-2-isopropenyl-8,9-dimethoxychromeno[3,4-b]furo[2,3-h]chromen-6-one (Rotenone) |
PL |
201-501-9 |
83-79-4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
85 |
Symclosene |
DE |
201-782-8 |
87-90-1 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
92 |
Biphenyl-2-ol |
ES |
201-993-5 |
90-43-7 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
113 |
3-Phenyl-propen-2-al (Cinnamaldehyde) |
PL |
203-213-9 |
104-55-2 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117 |
Geraniol |
FR |
203-377-1 |
106-24-1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
122 |
Glyoxal |
FR |
203-474-9 |
107-22-2 |
|
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
133 |
Hexa-2,4-dienoic acid (Sorbic acid) |
DE |
203-768-7 |
110-44-1 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
171 |
2-Phenoxyethanol |
IT |
204-589-7 |
122-99-6 |
x |
x |
|
x |
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
180 |
Sodium dimethylarsinate (Sodium Cacodylate) |
PT |
204-708-2 |
124-65-2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
185 |
Tosylchloramide sodium (Chloramin T) |
ES |
204-854-7 |
127-65-1 |
|
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
187 |
Potassium dimethyldithiocarbamate |
SE |
204-875-1 |
128-03-0 |
|
|
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
188 |
Sodium dimethyldithiocarbamate |
SE |
204-876-7 |
128-04-1 |
|
|
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
227 |
2-Thiazol-4-yl-1H-benzoimidazole (Thiabendazole) |
ES |
205-725-8 |
148-79-8 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
235 |
Diuron |
DK |
206-354-4 |
330-54-1 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
239 |
Cyanamide |
DE |
206-992-3 |
420-04-2 |
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
283 |
Terbutryn |
SK |
212-950-5 |
886-50-0 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
292 |
(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (d-Tetramethrin) |
DE |
214-619-0 |
1166-46-7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
321 |
Monolinuron |
HU |
217-129-5 |
1746-81-2 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
330 |
N-(3-Aminopropyl)-N-dodecylpropane-1,3-diamine (Diamine) |
PT |
219-145-8 |
2372-82-9 |
|
x |
x |
x |
|
x |
|
x |
|
|
x |
x |
x |
|
|
|
|
|
336 |
2,2'-Dithiobis[N-methylbenzamide] (DTBMA) |
PL |
219-768-5 |
2527-58-4 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
339 |
1,2-Benzisothiazol-3(2H)-one (BIT) |
ES |
220-120-9 |
2634-33-5 |
|
x |
|
|
|
x |
|
|
x |
|
x |
x |
x |
|
|
|
|
|
341 |
2-Methyl-2H-isothiazol-3-one (MIT) |
SI |
220-239-6 |
2682-20-4 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
346 |
Sodium dichloroisocyanurate dihydrate |
DE |
220-767-7 |
51580-86-0 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
345 |
Troclosene sodium |
DE |
220-767-7 |
2893-78-9 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
348 |
Mecetronium ethylsulfate (MES) |
PL |
221-106-5 |
3006-10-8 |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
359 |
Formaldehyde released from (Ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (EGForm)) |
PL |
222-720-6 |
3586-55-8 |
|
|
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
365 |
Pyridine-2-thiol 1-oxide, sodium salt (Sodium pyrithione) |
SE |
223-296-5 |
3811-73-2 |
|
x |
|
|
|
x |
x |
|
x |
x |
|
|
x |
|
|
|
|
|
368 |
Methenamine 3-chloroallylochloride (CTAC) |
PL |
223-805-0 |
4080-31-3 |
|
|
|
|
|
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
377 |
2,2',2"-(Hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (HHT) |
PL |
225-208-0 |
4719-04-4 |
|
|
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
382 |
Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (TMAD) |
ES |
226-408-0 |
5395-50-6 |
|
|
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
392 |
Methylene dithiocyanate |
FR |
228-652-3 |
6317-18-6 |
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
393 |
1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (DMDMH) |
PL |
229-222-8 |
6440-58-0 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
397 |
Didecyldimethylammonium chloride (DDAC) |
IT |
230-525-2 |
7173-51-5 |
x |
x |
|
|
|
x |
|
|
|
x |
x |
x |
|
|
|
|
|
|
401 |
Silver |
SE |
231-131-3 |
7440-22-4 |
|
x |
|
x |
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
405 |
Sulfur dioxide generated from sulfur by combustion |
DE |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
424 |
Active bromine generated from sodium bromide and sodium hypochlorite |
NL |
|
|
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1030 |
Active bromine generated from sodium bromide and calcium hypochlorite |
NL |
|
|
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1031 |
Active bromine generated from sodium bromide and chlorine |
NL |
|
|
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1032 |
Active bromine generated from sodium bromide by electrolysis |
NL |
|
|
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1033 |
Active bromine generated from hypobromous acid and urea and bromourea |
NL |
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1034 |
Active bromine generated from sodium hypobromite and N-bromosulfamate and sulfamic acid |
NL |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
434 |
Tetramethrin |
DE |
231-711-6 |
7696-12-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
439 |
Hydrogen peroxide |
FI |
231-765-0 |
7722-84-1 |
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1036 |
Hydrogen peroxide released from sodium percarbonate |
FI |
|
|
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
444 |
7a-Ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole (EDHO) |
PL |
231-810-4 |
7747-35-5 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
450 |
Silver nitrate |
SE |
231-853-9 |
7761-88-8 |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
453 |
Disodium peroxodisulfate |
PT |
231-892-1 |
7775-27-1 |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
432 |
Active chlorine released from sodium hypochlorite |
IT |
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
455 |
Active chlorine released from calcium hypochlorite |
IT |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
457 |
Active chlorine released from chlorine |
IT |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
458 |
Monochloramine generated from ammonium sulfate and a chlorine source |
FR |
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1016 |
Silver chloride |
SE |
232-033-3 |
7783-90-6 |
x |
x |
|
|
|
x |
x |
|
x |
|
|
|
|
|
|
|
|
|
1076 |
Silver-polyethylenimine-chloride |
SE |
|
|
x |
x |
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
491 |
Chlorine dioxide |
DE |
233-162-8 |
10049-04-4 |
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1037 |
Chlorine dioxide generated from sodium chlorite by electrolysis |
PT |
|
|
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1038 |
Chlorine dioxide generated from sodium chlorite by acidification |
PT |
|
|
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1039 |
Chlorine dioxide generated from sodium chlorite by oxidation |
PT |
|
|
|
x |
x |
x |
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
1040 |
Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid |
PT |
|
|
|
x |
|
|
x |
|
|
|
|
|
x |
x |
|
|
|
|
|
|
494 |
2,2-Dibromo-2-cyanoacetamide (DBNPA) |
DK |
233-539-7 |
10222-01-2 |
|
x |
|
x |
|
x |
|
|
|
|
x |
x |
|
|
|
|
|
|
1022 |
Dialuminium chloride pentahydroxide |
NL |
234-933-1 |
12042-91-0 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1075 |
Reaction products of aluminium trihydroxide and hydrochloric acid and aluminium and water |
NL |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
Bromide activated chloramine (BAC) generated from precursors ammonium bromide and sodium hypochlorite |
SE |
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
522 |
Pyrithione zinc |
SE |
236-671-3 |
13463-41-7 |
|
x |
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
x |
|
524 |
Dodecylguanidine monohydrochloride |
ES |
237-030-0 |
13590-97-1 |
|
|
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
529 |
Active bromine generated from bromine chloride |
NL |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
531 |
(Benzyloxy)methanol |
AT |
238-588-8 |
14548-60-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
550 |
D-Gluconic acid, compound with N,N"-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1) (CHDG) |
PT |
242-354-0 |
18472-51-0 |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
554 |
p-[(Diiodomethyl)sulphonyl]toluene |
CH |
243-468-3 |
20018-09-1 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
559 |
(Benzothiazol-2-ylthio)methyl thiocyanate (TCMTB) |
NO |
244-445-0 |
21564-17-0 |
|
|
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
562 |
2-Methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate (Prallethrin) |
EL |
245-387-9 |
23031-36-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
566 |
Reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT) |
AT |
|
|
|
x |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
571 |
2-Octyl-2H-isothiazol-3-one (OIT) |
FR |
247-761-7 |
26530-20-1 |
|
|
|
|
|
x |
x |
|
x |
x |
x |
|
x |
|
|
|
|
|
577 |
Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride |
ES |
248-595-8 |
27668-52-6 |
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
588 |
Bromochloro-5,5-dimethylimidazolidine-2,4-dione (BCDMH) |
NL |
251-171-5 |
32718-18-6 |
|
x |
|
|
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
590 |
3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon) |
DE |
251-835-4 |
34123-59-6 |
|
|
|
|
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
599 |
S-[(6-Chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (Azamethiphos) |
IT |
252-626-0 |
35575-96-3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
608 |
Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammonium chloride |
PL |
255-451-8 |
41591-87-1 |
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
1045 |
Eucalyptus citriodora oil, hydrated, cyclized |
CZ |
|
1245629-80-4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
1046 |
Cymbopogon winterianus oil, fractionated, hydrated, cyclized |
CZ |
Not available |
Not available |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
619 |
3-Iodo-2-propynylbutylcarbamate (IPBC) |
DK |
259-627-5 |
55406-53-6 |
|
|
|
|
|
|
x |
|
x |
x |
|
|
|
|
|
|
|
|
620 |
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1) (THPS) |
MT |
259-709-0 |
55566-30-8 |
|
|
|
|
|
x |
|
|
|
|
x |
x |
|
|
|
|
|
|
648 |
4,5-Dichloro-2-octylisothiazol-3(2H)-one (4,5-Dichloro- 2-octyl-2H- isothiazol-3-one (DCOIT)) |
NO |
264-843-8 |
64359-81-5 |
|
|
|
|
|
|
x |
|
x |
x |
x |
|
|
|
|
|
|
|
656 |
Reaction products of paraformaldehyde and 2- hydroxypropylamine (ratio 3:2) (MBO) |
AT |
|
|
|
x |
|
|
|
x |
|
|
|
|
x |
x |
x |
|
|
|
|
|
667 |
Alkyl (C12-18) dimethylbenzyl ammonium chloride (ADBAC (C12-18)) |
IT |
269-919-4 |
68391-01-5 |
x |
x |
x |
x |
|
|
|
|
|
x |
x |
x |
|
|
|
|
|
x |
671 |
Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) |
IT |
270-325-2 |
68424-85-1 |
x |
x |
|
|
|
|
|
|
|
x |
x |
x |
|
|
|
|
|
x |
673 |
Didecyldimethylammonium chloride (DDAC (C8-10)) |
IT |
270-331-5 |
68424-95-3 |
x |
x |
x |
x |
|
x |
|
|
|
x |
x |
x |
|
|
|
|
|
|
690 |
Quaternary ammonium compounds, benzyl-C12-18-alkyldimethyl, salts with 1,2-benzisothiazol-3(2H)-one 1,1-dioxide (1:1) (ADBAS) |
MT |
273-545-7 |
68989-01-5 |
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
691 |
Sodium N-(hydroxymethyl)glycinate |
AT |
274-357-8 |
70161-44-3 |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
693 |
Pentapotassium bis(peroxymonosulfate)bis(sulfate) (KPMS) |
SI |
274-778-7 |
70693-62-8 |
|
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
939 |
Active chlorine generated from sodium chloride by electrolysis |
SK |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
1049 |
Active chlorine generated from sodium chloride and pentapotassium bis(peroxymonosulfate)bis(sulfate) |
SI |
|
|
|
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
1050 |
Active chlorine generated from seawater (sodium chloride) by electrolysis |
FR |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
1051 |
Active chlorine generated from magnesium chloride hexahydrate and potassium chloride by electrolysis |
FR |
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1054 |
Active chlorine generated from sodium N- chlorosulfamate |
SI |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
x |
|
|
|
|
|
|
701 |
Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-) (MMPP) |
PL |
279-013-0 |
84665-66-7 |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1024 |
Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide |
DE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
724 |
Alkyl (C12-C14) dimethylbenzylammonium chloride (ADBAC (C12-C14)) |
IT |
287-089-1 |
85409-22-9 |
x |
x |
x |
x |
|
|
|
|
|
x |
x |
x |
|
|
|
|
|
x |
725 |
Alkyl (C12-C14) dimethyl(ethylbenzyl)ammonium chloride (ADEBAC (C12-C14)) |
IT |
287-090-7 |
85409-23-0 |
x |
x |
x |
x |
|
|
|
|
|
x |
x |
x |
|
|
|
|
|
x |
1057 |
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvent |
ES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
1058 |
Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide |
ES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
|
744 |
Lavender, Lavandula hybrida, ext./Lavandin oil |
PT |
294-470-6 |
91722-69-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
779 |
Reaction products of: glutamic acid and N-(C12-C14-alkyl)propylenediamine (Glucoprotamin) |
DE |
403-950-8 |
164907-72-6 |
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
785 |
6-(Phthalimido)peroxyhexanoic acid (PAP) |
IT |
410-850-8 |
128275-31-0 |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
791 |
2-Butyl-benzo[d]isothiazol-3-one (BBIT) |
CZ |
420-590-7 |
4299-07-4 |
|
|
|
|
|
x |
x |
|
x |
x |
|
|
x |
|
|
|
|
|
792 |
Chlorine dioxide generated from tetrachlorodecaoxide complex (TCDO) by acidification |
DE |
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
811 |
Silver sodium hydrogen zirconium phosphate |
SE |
422-570-3 |
265647-11-8 |
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
797 |
cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (cis CTAC) |
PL |
426-020-3 |
51229-78-8 |
|
|
|
|
|
x |
|
|
|
|
|
|
x |
|
|
|
|
|
1014 |
Silver zeolite |
SE |
Not available |
Not available |
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
152 |
Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with bromine and chlorine (DCDMH) |
NL |
Not available |
Not available |
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
459 |
Reaction mass of titanium dioxide and silver chloride |
SE |
Not available |
Not available |
x |
x |
|
|
|
x |
x |
|
x |
x |
x |
|
|
|
|
|
|
|
777 |
Reaction products of 5,5-dimethylhydantoin, 5-ethyl-5-methylhydantoin with chlorine (DCEMH) |
NL |
Not available |
Not available |
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
810 |
Silver phosphate glass |
SE |
Not available |
308069-39-8 |
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
1077 |
Silver borophosphate glass |
SE |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
1078 |
Silver phosphoborate glass |
SE |
|
|
|
x |
|
|
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
824 |
Silver zinc zeolite |
SE |
Not available |
130328-20-0 |
|
x |
|
x |
|
|
x |
|
x |
|
|
|
|
|
|
|
|
|
1013 |
Silver copper zeolite |
SE |
Not available |
130328-19-7 |
|
|
|
x |
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
1017 |
Silver adsorbed on silicon dioxide (as a nanomaterial in the form of a stable aggregate with primary particles in the nanoscale) |
SE |
Not available |
Not available |
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
854 |
(RS)-3-Allyl-2-methyl-4-oxocyclopent-2-enyl-(1R,3R;1R,3S)-2,2-dimethyl-3-(2-methylprop-1-enyl)-cyclopropanecarboxylate (mixture of 4 isomers 1R trans, 1R: 1R trans, 1S: 1R cis, 1R: 1R cis, 1S 4:4:1:1) (d-Allethrin) |
DE |
Plant protection product |
231937-89-6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
843 |
4-Bromo-2-(4-chlorophenyl)-1-ethoxymethyl-5-trifluoromethylpyrrole-3-carbonitrile (Chlorfenapyr) |
PT |
Plant protection product |
122453-73-0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
859 |
Polymer of N-Methylmethanamine (Einecs 204-697-4 with (chloromethyl)oxirane (Einecs 203-439-8)/Polymeric quaternary ammonium chloride (PQ Polymer) |
HU |
Polymer |
25988-97-0 |
|
x |
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
869 |
Poly(oxy-1,2-ethanediyl),.alpha.-[2-(didecylmethylammonio)ethyl]-.omega.-hydroxy-, propanoate (salt) (Bardap 26) |
IT |
Polymer |
94667-33-1 |
|
x |
|
x |
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
872 |
N-Didecyl-N-dipolyethoxyammonium borate/Didecylpolyoxethylammonium borate (Polymeric betaine) |
EL |
Polymer |
214710-34-6 |
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
1070 |
Orange, sweet, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis, Rutaceae. |
CH |
232-433-8 |
8028-48-6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
1071 |
Garlic, ext. Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Allium sativum, Liliaceae. |
AT |
232-371-1 |
8008-99-9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
1072 |
Brandy |
tbd |
Not available |
Not available |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
1073 |
Peanut butter |
BE |
Not available |
Not available |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
1074 |
Copper, powder |
FR |
231-159-6 |
7440-50-8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
ANNEX III
Time limits
Product-types |
Time limits for submitting the assessment report pursuant to Article 6(3)(b) |
Time limits for starting the preparation of the opinion pursuant to Article 7(2)(b) |
8, 14, 16, 18, 19 and 21 |
31.12.2015 |
31.3.2016 |
3, 4 and 5 |
31.12.2016 |
31.3.2017 |
1 and 2 |
31.12.2018 |
31.3.2019 |
6 and 13 |
31.12.2019 |
31.3.2020 |
7, 9 and10 |
31.12.2020 |
31.3.2021 |
11, 12, 15, 17, 20 and 22 |
31.12.2022 |
►C1 30.9.2023 ◄ |
( 1 ) Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013 on the fees and chargespayable to the European Chemicals Agency pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, 19.6.2013, p. 17).
( 2 ) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).