Borater og borsyre: Anbefalt for prioritering for godkjenning ASA
Bor til bruk landbruket Bor er et av syv essensielle mikronæringsstoffer for planter og bør være kontinuerlig tilgjengelig for opptak via røttene Bor bidrar til å danne og forsterke celleveggene og er spesielt viktig før blomstring, da det er avgjørende for reproduksjon prosessen. Bor er et allment forekommende element og finnes som mineraler i jordskorpen i en konsentrasjon på 8 mg / kg i gjennomsnitt Lave bor nivåer fører til dårlig planteutvikling og raskt voksende vev er spesielt utsatt. I Europa er det mangel på bor i jordsmonnen i hovedsak i Skandinavia og Nord-Europa Borsyre, natrium tetraborat og dibor trioksyd er klassifisert som Repr. 1B over en spesifikk konsentrasjonsgrense ( 5.5%). 2
Bor er et essensielt mikronæringsstoffer i landbruket Gjødsel som inneholder bor Bor som plantenæring bør være i en vannløselig form H BO H + BO - H + H + Når borsalter blir løst i vann, er borsyre den aktive formen. BO - BO - BO - BO - BO - Planter tar opp bor i form av vannløselig borsyre anion
From the identification as a SVHC to the ban of the substance Criteria for identification (REACH regulation) CMR, PBT/vPvb Art 57(f) substances i.e. Endocrine disruptors Who starts the process Each MS contribute to evaluate The substances which meet the Criteria for identification Who prioritize the process ECHA recommends priority substances for inclusion in Annex XIV. Criteria are PBT/vPvB properties or Wide dispersive use, or high volumes SVHC identification Inclusion in Candidate List Recommendation for inclusion in Annex XIV Commission adopt recommendation Amendment of Annex XIV Substances containing boron Submitted by Germany 10/02/2010 MSC agreed Boric Acid as SVHC in 10/06/2010 Draft September 2014, Final July 2015 MS evaluation of substance MS Annex XV Dossier submission 45 days public consultation MSC unanimous agreement (if any comment from consultation) Twice a year ECHA publish C. List update (Triggers to Communication Obligations down the S.C.) Once a year ECHA draft recommendation 90 days public consultation MSC opinion ECHA Final recommendation submission to EU. Commission European Commission Set exemptions if any Set transitional arrangements if any European Commission Set sunset date (Minimum is 6 months after publication) Application for Authorization deadline is 18 months before Sunset date Time to start to interact with Authorities 5
Fertilizer Europe kommentar sendt til offentlig høring 1. Bor er et viktig plante mikronæringsstoffer som bønder må ha tilgang til for å unngå Bor mangel og påfølgende tap av avling 2. Det finnes ikke egnede alternativer tilgjengelig som enten ikke er klassifisert som giftig eller som har lav løselighet og dermed begrenset tilgjengelighet for planter. Å ikke tillate formulering av Bor-holdig gjødsel basert på borsyre i Europa, vil skape en konkurranse vrengning mot naboland utenfor EU (Sveits, Tyrkia, Russland) der det fortsatt er lov å bruke borsyre og bor salter for formulering av gjødsel. => Mulige samfunnsøkonomiske konsekvensene av en godkjenningsordning for Borsyre i gjødsel. Å blande/formulere gjødsel med borsyre og andre bor-salter bør ikke være innenfor rammen av godkjenningsordningen. Konkurranse vridning 6
A.1.5. Aspects not considered in ECHA s prioritisation: 4. Control of risks 5. Availability of suitable alternatives A.2.20: Claim that the socio-economic impact of inclusion of the substance in Annex XIV would be very high and result in a high burden for industry ECHA Response document 7
C.2. Responses to exemption requests referring to other legislation 01/07/2015 Use Legislation Draft response Use in mixtures for the supply for general public and in mixtures < SCL (including fertilisers and photographic processing chemicals) Use in fertilisers (as a source of the micronutrient boron) Annex XVII to REACH Regulation and general exemptions Please see C.1 Process information and in particular C.1.2. Generic exemptions which provides further information on generic exemptions from authorisation. Consumer uses of these borate substances, as such or in classification concentration limit are not in the scope of authorisation. Professional or industrial uses (e.g. relevant formulation steps) of the borate substances as such or in mixtures above the classification concentration limit would require authorisation. Please see C.1 Process information and in particular C.1.2. Generic exemptions which provides further information on generic exemptions from authorisation. We would suggest that you examine whether the use of your substance can be regarded as fulfilling any of the exemption requirements, however it appears that this use of borate compounds does not appear to be specifically exempted. Boron substances are used in fertilisers as a source of the micro-nutrient boron according to the Regulation (EC) No. 200/200 (Fertilisers Regulation). It needs to be examined whether an exemption can be granted under Article 58(2) REACH. For the use of the substance in fertilisers, there appears to be no specific EU legislation imposing minimum requirements relating to the protection of human health and the environment in order to ensure that the risk is properly controlled. Therefore it does not appear that this use would merit an exemption under Art 58(2). A potential streamlined / simplified authorisation process is being considered where an Annex XIV substance is used as a source of a biologically essential element (see document CA/81/2014 of the 16th CARACAL meeting instructions on how to access CARACAL documents are available at http://ec.europa.eu/enterprise/sectors/chemicals/reach/caracal/index_en.htm ). ECHA Response document 8
Resultat av prioritisering 9
Minority position of the Czech Republic, Poland, Slovakia, Slovenia, Croatia and Romania on the inclusion of the boron compounds into 6th Recommendation as candidate substances for listing in Annex XIV of REACH The representatives on the Member State Committee for the countries named above do not agree with boron compounds recommendation for inclusion for Annex XIV of REACH: From the agriculture point of view, boron is an essential micronutrient for the plants and cannot be replaced by another element. Its deficit results in a decrease in yield and deterioration of plant quality. A wide range of multinutrients NPK fertilisers available on the market has an average borates concentration of from 0.01% to 1%, and single-nutrient boron fertilisers contain boron even in amounts greater than 10%. OPINION OF THE MEMBER STATE COMMITTEE ON THE SIXTH DRAFT RECOMMENDATION OF THE PRIORITY SUBSTANCES AND ANNEX XIV ENTRIES 10
Boric acid, sodium tetraborate and diboron trioxide are recommended for prioritization for inclusion in Annex XIV because classified as Repr. 1B above a Specific Concentration Limit (C 5.5%). OPINION OF THE MEMBER STATE COMMITTEE ON THE SIXTH DRAFT RECOMMENDATION OF THE PRIORITY SUBSTANCES AND ANNEX XIV ENTRIES 11
EU gjødsel industri x EU marked Ikke tillat å lage borholdig gjødsel i EU x Bruk av bor i landbruket (<SCL) tillat i EU Tillaging av borholdig gjødsel tillat utenfor EU x 12