natgillin/translations-raw huggingface dataset:
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
SPREJELA NASLEDNJO UREDBO:
HAS ADOPTED THIS REGULATION:
Propan-1-ol se odobri kot aktivna snov za uporabo v biocidnih proizvodih 1., 2. in 4. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
Propan-1-ol is approved as an active substance for use in biocidal products of product-types 1, 2 and 4, subject to the specifications and conditions set out in the Annex.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 8. novembra 2017
The President
Delegirana uredba Komisije (EU) št. 1062/2014 z dne 4. avgusta 2014 o delovnem programu za sistematično preverjanje vseh obstoječih aktivnih snovi, ki jih vsebujejo biocidni proizvodi, iz Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta (UL L 294, 10.10.2014, str. 1).
OJ L 167, 27.6.2012, p. 1.
PRILOGA
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).
Splošno ime
Common Name
Identifikacijska številka
Identification Numbers
Datum odobritve
Minimum degree of purity of the active substance [1]
Datum prenehanja veljavnosti odobritve
Date of approval
Vrsta proizvoda
EC No: 200-746-9
CAS: 71-23-8
CAS No: 71-23-8
1. maj 2019
1 May 2019
30. april 2029
30 April 2029
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi pogoji:
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;
Zaradi ugotovljenih tveganj pri ocenjenih uporabah se pri oceni proizvoda posebna pozornost nameni poklicnim uporabnikom.
in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.
Dovoljenja za biocidne proizvode se izdajo pod naslednjim pogojem:
The authorisations of biocidal products are subject to the following condition:
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;
Zaradi ugotovljenih tveganj pri ocenjenih uporabah se pri oceni proizvoda posebna pozornost nameni poklicnim uporabnikom.
in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users;
Za proizvode, ki lahko povzročajo ostanke v živilih ali krmi, se preveri, ali je treba določiti nove ali spremeniti obstoječe mejne vrednosti ostankov (MRL) v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta [2] ali Uredbo Evropskega parlamenta in Sveta (ES) št. 396/2005 [3], in sprejmejo se vsi ustrezni ukrepi za zmanjšanje tveganja, da se veljavne mejne vrednosti ostankov ne presežejo.
for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council [2] or Regulation (EC) No 396/2005 of the European Parliament and of the Council [3] shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Čistost, navedena v tem stolpcu, je bila minimalna stopnja čistosti ocenjene aktivne snovi.
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Uredba (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (UL L 152, 16.6.2009, str. 11).
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Uredba Evropskega parlamenta in Sveta (ES) št. 396/2005 z dne 23. februarja 2005 o mejnih vrednostih ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora ter o spremembi Direktive Sveta 91/414/EGS (UL L 70, 16.3.2005, str.
Whereas: (1) Commission Delegated Regulation (EU) No 1062/2014 [2] establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products.
Delegirana uredba Komisije (EU) št. 1062/2014 [2] določa seznam obstoječih aktivnih snovi, ki jih je treba oceniti zaradi njihove morebitne odobritve za uporabo v biocidnih proizvodih.
Commission Implementing Regulation (EU) 2017/2002
Izvedbena uredba Komisije (EU) 2017/2002
approving L(+) lactic acid as an existing active substance for use in biocidal products of product-types 2, 3 and 4
o odobritvi L(+) mlečne kisline kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 2., 3. in 4. vrste proizvodov
That list includes L(+) lactic acid.
Nemčija, ki je bila imenovana za pristojni ocenjevalni organ, je 3. maja 2016 predložila poročila o oceni skupaj s svojimi priporočili.
L(+) lactic acid has been evaluated for use in products of product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, product-type 3, veterinary hygiene, and product type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.
V skladu s členom 7(2) Delegirane uredbe (EU) št. 1062/2014 je Odbor za biocidne pripravke ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 27. aprila 2017 oblikoval mnenja Evropske agencije za kemikalije.
Germany was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 3 May 2016.
Glede na navedena mnenja je za biocidne proizvode 2., 3. in 4. vrste proizvodov, ki vsebujejo L(+) mlečno kislino, mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjeni nekatere specifikacije in pogoji za njihovo uporabo.
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 27 April 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
Zato je primerno L(+) mlečno kislino odobriti za uporabo v biocidnih proizvodih 2., 3. in 4. vrste proizvodov, pod pogojem da je ta v skladu z nekaterimi specifikacijami in pogoji.
According to those opinions, biocidal products of product-types 2, 3 and 4 and containing L(+) lactic acid may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Pred odobritvijo aktivne snovi bi bilo treba zagotoviti ustrezno obdobje, da bi se zainteresiranim stranem omogočilo, da sprejmejo potrebne pripravljalne ukrepe za izpolnitev novih zahtev.
It is therefore appropriate to approve L(+) lactic acid for use in biocidal products of product-types 2, 3 and 4, subject to compliance with certain specifications and conditions.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne pripravke –
HAS ADOPTED THIS REGULATION:
L(+) mlečna kislina se odobri kot aktivna snov za uporabo v biocidnih proizvodih 2., 3. in 4. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
L(+) lactic acid is approved as an active substance for use in biocidal products of product-types 2, 3 and 4, subject to the specifications and conditions set out in the Annex.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Product type
L(+) mlečna kislina
L(+) lactic acid
idroksipropanojska kislina
ydroxypropanoic acid
ES: 201-196-2
CAS No: 79-33-4
CAS: 79-33-4
≥ 955 g/kg (dry weight)
≥ 955 g/kg (suha snov)
1 May 2019
1. maj 2019
30 April 2029
30. april 2029
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to groundwater for products used in animal housings leading to exposure of the environment via the application of manure on agricultural land.
Zaradi ugotovljenih tveganj v zvezi z ocenjenimi uporabami se pri oceni proizvoda posebna pozornost nameni podzemni vodi pri proizvodih, ki se uporabljajo v bivalnih prostorih za živali, kar povzroči izpostavljenost okolja zaradi uporabe gnoja na kmetijskem zemljišču.
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.
Zaradi ugotovljenih tveganj pri ocenjenih uporabah se pri oceni proizvoda posebna pozornost nameni poklicnim uporabnikom.
Commission Implementing Regulation (EU) 2017/2003
Izvedbena uredba Komisije (EU) 2017/2003
approving fludioxonil as an active substance for use in biocidal products of product-types 7, 9 and 10
o odobritvi fludioksonila kot aktivne snovi za uporabo v biocidnih proizvodih 7., 9. in 10. vrste proizvodov
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products [1], and in particular Article 9(1)(a) thereof,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov [1] ter zlasti člena 9(1)(a) Uredbe, ob upoštevanju naslednjega:
Denmark submitted the assessment reports together with its recommendations on 5 April 2016 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
Iz navedenega mnenja je razvidno, da je za biocidne proizvode 7., 9. in 10. vrste proizvodov, ki vsebujejo fludioksonil, mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjeni nekatere specifikacije in pogoji glede njihove uporabe.
The opinions of the European Chemicals Agency were formulated on 2 March 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
Zato je primerno fludioksonil odobriti za uporabo v biocidnih proizvodih 7., 9. in 10. vrste proizvodov, če je ta v skladu z nekaterimi specifikacijami in pogoji.
According to those opinions, biocidal products of product-types 7, 9 and 10 and containing fludioxonil may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Ker fludioksonil izpolnjuje merila iz Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [2] za snov, ki je zelo obstojna, bi bilo treba izdelke, ki so bili tretirani s fludioksonilom ali ga vsebujejo, pri dajanju na trg ustrezno označiti.
It is therefore appropriate to approve fludioxonil for use in biocidal products of product-types 7, 9 and 10, subject to compliance with certain specifications and conditions.
Pred odobritvijo aktivne snovi bi moralo biti na voljo ustrezno obdobje, v katerem bi zainteresirane strani lahko sprejele potrebne pripravljalne ukrepe za izpolnitev novih zahtev.
Since fludioxonil meets the criteria laid down in Regulation (EC) No 1907/2006 of the European Parliament and of the Council [2] for being very persistent, treated articles treated with or incorporating fludioxonil should be appropriately labelled when placed on the market.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne pripravke –
HAS ADOPTED THIS REGULATION:
Fludioksonil se odobri kot aktivna snov za uporabo v biocidnih proizvodih 7., 9. in 10. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
Fludioxonil is approved as an active substance for use in biocidal products of product-types 7, 9 and 10, subject to the specifications and conditions set out in the Annex.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
V Bruslju, 8. novembra 2017
The President
Uredba (ES) št. 1907/2006 Evropskega parlamenta in Sveta z dne 18. decembra 2006 o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) ter o ustanovitvi Evropske agencije za kemikalije in o spremembi Direktive 1999/45/ES ter o razveljavitvi Uredbe Sveta (EGS) št. 793/93 in Uredbe Komisije (ES) št. 1488/94 ter Direktive Sveta 76/769/EGS in direktiv Komisije 91/155/EGS, 93/67/EGS, 93/105/ES in 2000/21/ES (UL L 396, 30.12.2006, str. 1).
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).
Splošno ime
Product type
Fludioksonil
Fludioxonil
4-(2,2-difluoro-1,3-benzodioksol-4-il)-1H-pirol-3-karbonitril
4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile
ES: ni na voljo
CAS No: 131341-86-1
CAS: 131341-86-1
1 April 2018
1. april 2018
31 March 2028
31. marec 2028
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, ki je zajeta v vlogi za izdajo dovoljenja, ki pa ni pa bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to industrial and professional users.
Zaradi ugotovljenih tveganj v zvezi z ocenjenimi uporabami se pri oceni proizvoda posebna pozornost nameni industrijskim in poklicnim uporabnikom.
The person responsible for the placing on the market of a treated article treated with or incorporating fludioxonil shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Oseba, odgovorna za dajanje na trg izdelka, ki je tretiran s fludioksonilom ali ga vsebuje, zagotovi, da so na oznaki navedenega tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
Commission Implementing Regulation (EU) 2017/2004
Izvedbena uredba Komisije (EU) 2017/2004
approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in biocidal products of product-type 12
o odobritvi 2-metilizotiazol-3(2H)-ona kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 12. vrste proizvodov
That list includes 2-methylisothiazol-3(2H)-one.
Slovenija, ki je bila imenovana za pristojni ocenjevalni organ, je 7. aprila 2016 predložila poročilo o oceni, skupaj s svojimi priporočili.
ethylisothiazol-3(2H)-one has been evaluated for use in products of product-type 12, slimicides, as described in Annex V to Regulation (EU) No 528/2012.
V skladu s členom 7(2) Delegirane uredbe (EU) št. 1062/2014 je Odbor za biocidne pripravke ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 2. marca 2017 oblikoval mnenje Evropske agencije za kemikalije.
Slovenia was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 7 April 2016.
Iz navedenega mnenja je razvidno, da je za biocidne proizvode 12. vrste proizvodov, ki vsebujejo 2-metilizotiazol-3(2H)-on, mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjeni nekatere specifikacije in pogoji za njihovo uporabo.
In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 2 March 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
Zato je primerno 2-metilizotiazol-3(2H)-on odobriti za uporabo v biocidnih proizvodih 12. vrste proizvodov, če je ta v skladu z nekaterimi specifikacijami in pogoji.
According to that opinion, biocidal products of product-type 12 containing 2-methylisothiazol-3(2H)-one may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Ker 2-metilizotiazol-3(2H)-on izpolnjuje merila za razvrstitev kot povzročitelj preobčutljivosti kože podkategorije 1A, kot so opredeljena v Prilogi I k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta [3], bi bilo treba izdelke, ki so bili tretirani z 2-metilizotiazol-3(2H)-onom ali ga vsebujejo, pri dajanju na trg ustrezno označiti.
It is therefore appropriate to approve 2-methylisothiazol-3(2H)-one for use in biocidal products of product-type 12, subject to compliance with certain specifications and conditions.
Pred odobritvijo aktivne snovi bi moralo biti na voljo ustrezno obdobje, v katerem bi zainteresirane strani lahko sprejele potrebne pripravljalne ukrepe za izpolnitev novih zahtev.
Since 2-methylisothiazol-3(2H)-one meets the criteria for classification as skin sensitiser sub-category 1A as specified in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council [3], treated articles treated with or incorporating 2-methylisothiazol-3(2H)-one should be appropriately labelled when placed on the market.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne pripravke –
HAS ADOPTED THIS REGULATION:
etilizotiazol-3(2H)-on se odobri kot aktivna snov za uporabo v biocidnih proizvodih 12. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
ethylisothiazol-3(2H)-one is approved as an active substance for use in biocidal products of product-type 12, subject to the specifications and conditions set out in the Annex.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
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).
PRILOGA
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Splošno ime
Product type
etilizotiazol-3(2H)-on
ethylisothiazol-3(2H)-one
Št.
IUPAC Name:
ES: 220-239-6
EC No: 220-239-6
Št.
CAS No: 2682-20-4
CAS: 2682-20-4
1 April 2019
1. april 2019
31 March 2029
31. marec 2029
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
Pri oceni proizvoda se posebna pozornost nameni vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, ki je zajeta v vlogi za izdajo dovoljenja, ni pa bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:
Zaradi ugotovljenih tveganj v zvezi z ocenjenimi uporabami se pri oceni proizvoda posebna pozornost nameni:
surface water and sewage treatment plants.
površinski vodi in napravam za čiščenje odpadnih vod.
The person responsible for the placing on the market of a treated article treated with or incorporating 2-methylisothiazol-3(2H)-one shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Oseba, odgovorna za dajanje na trg izdelka, ki je bil tretiran z 2-metilizotiazol-3(2H)-onom ali ga vsebuje, zagotovi, da so na oznaki tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
Commission Implementing Regulation (EU) 2017/2005
Izvedbena uredba Komisije (EU) 2017/2005
approving margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide as an existing active substance for use in biocidal products of product-type 19
o odobritvi margoza ekstrakta, hladno stisnjenega olja iz oluščenih semen Azadirachta indica, ekstrahiranega s superkritičnim ogljikovim dioksidom, kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 19. vrste proizvodov
That list includes margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide.
Nemčija, ki je bila imenovana za ocenjevalni pristojni organ, je 3. decembra 2015 predložila poročilo o oceni skupaj s svojimi priporočili.
Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide has been evaluated for use in products of product-type 19, repellents and attractants, as described in Annex V to Regulation (EU) No 528/2012.
V skladu s členom 7(2) Delegirane uredbe (EU) št. 1062/2014 je Odbor za biocidne pripravke ob upoštevanju ugotovitev pristojnega ocenjevalnega organa 3. marca 2017 oblikoval mnenje Evropske agencije za kemikalije.
Germany was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 3 December 2015.
Iz navedenega mnenja je razvidno, da je za biocidne proizvode 19. vrste proizvodov, ki vsebujejo margoza ekstrakt, hladno stisnjeno olje iz oluščenih semen Azadirachta indica, ekstrahiran s superkritičnim ogljikovim dioksidom, mogoče pričakovati, da izpolnjujejo merila iz člena 19(1)(b) Uredbe (EU) št. 528/2012, če so izpolnjeni nekatere specifikacije in pogoji glede njihove uporabe.