Administrative konsekvenser af REACH Undersøgelse fra Erhvervs og Selskabstyrelsen Formøde Bilag 5

Agenda Essentielle REACH nøglebegreber a. Vurdering af sikkerhed ved anvendelse af kemikalier b. Anmeldelse af kemikaliets anvendelse c. Anvendelse af kemiske stoffer under godkendelsesordningen (Authorisation) Alt det Erhvervs- og Selskabsstyrelsens projekt ikke dækker. = REACH høringssvar November, 2003

Supply chain REACH nøglebegreber Chemical Safety Assessment (CSA)  Chemical Safety Report (CSR) Exposure scenario Exposure assessment Risk characterisation Authorisation Restriction RegistreringEvaluering PRODUCER/ IMPORTER DOWNSTREAM USER SDS SDS (extended) Identified use Conditions for use

Supply chain Import Unintended exposure Supply Chain Responsibility of Registrant: Establish the conditions for safe use of the chemicals in the whole supply chain. Consumer Professional Environment Exposure Goods Preparations Articles Substances Waste

Supply chain REACH nøglebegreber Chemical Safety Assessment (CSA)  Chemical Safety Report (CSR) Exposure scenario Exposure assessment Risk characterisation Authorisation Restriction RegistreringEvaluering PRODUCER/ IMPORTER DOWNSTREAM USER SDS SDS (extended) Identified use Conditions for use

Approx. # substances No registration 2006 REACH proces ,000 ”old” substances (EINECS) < 1 t70,000 >1000 t 3, t2, t t5,000 20,000 Registration

Approx. # substances No registration 2006 REACH proces < 1 t70,000 >1000 t 3, t2, t t5,000 20,000 Registration Evaluation

Approx. # substances No registration 2006 REACH proces < 1 t70,000 >1000 t 3, t2, t t5,000 20,000 Registration Evaluation Authorisation/

Approx. # substances No registration 2006 REACH proces < 1 t70,000 >1000 t 3, t2, t t5,000 20,000 Registration Evaluation Authorisation/ Restriction

Authorisation – Substances for Annex XIII Total estimated time approx months AGENCY 3rd part hearing EU COM MS Dossier Annex XIII CMR 1+2 EU COM

Authorisation – granting Applicant(s) Preparations Substances Article Application Total estimated time approx. 18 months AGENCY 3rd part hearing WWW Draft Decision EU COM EU Importer

Application for Authorisation (manufactor, importer, down stream user) 1.Identity of the substance 2.Name and contact details of the person 3.Request for authorisation, specifying use 4.Chemical Safety Report May include: a.Socio-economic analysis b.Analysis of the alternatives, incl. substitution plan

Supply chain REACH nøglebegreber Chemical Safety Assessment (CSA)  Chemical Safety Report (CSR) Exposure scenario Exposure assessment Risk characterisation Authorisation Restriction RegistreringEvaluering PRODUCER/ IMPORTER DOWNSTREAM USER SDS SDS (extended) Identified use Conditions for use

To be documented in a Chemical Safety Report Chemical Safety Assessment Hazard Assessment Health/Environmental No classification No PBT or vPvB Iterations Exposure assessment Exposure scenario (incl. Risk Reduction Measures) All identified uses from supply chain Risk characterisation PNEC/DNEL Classification PBT or vPvB

Chemical Safety Assessment Hazard Assessment Health/Environmental No classification No PBT or vPvB Exposure assessment Exposure scenario (incl. Risk Reduction Measures) Risk characterisation PNEC/DNEL Classification PBT or vPvB An example

Supply chain Exposure scenario - example Professional Exposure Preparations Import Unintended exposure Consumer Environment Goods Preparations Articles Substances Waste.

Exposure scenario – example Exposure routes Professional Skin contact Inhalation Oral Preparations.

Exposure scenario – example Plant operations Mixer ReceivalLoadingFilling Preparations Professional Storage Substance A (100%).

Chemical Safety Assessment Hazard Assessment Health/Environmental No classification No PBT or vPvB Exposure scenario (incl. Risk Reduction Measures) Risk characterisation PNEC/DNEL Classification PBT or vPvB An example Exposure assessment

Exposure assessment An example Mixer Substance A Generic exposure: 250 mg/kg Quantity loaded: 45 kg/day Professional Body weight 70 kg Specific exposure of Substance A: 250 mg/kg x 45 kg/day / 70 kg = 161 mg substance A / kg / day 100%

Chemical Safety Assessment Hazard Assessment Health/Environmental No classification No PBT or vPvB Exposure assessment Exposure scenario (incl. Risk Reduction Measures) Risk characterisation Classification PBT or vPvB PNEC/DNEL

Derived No Effect Level (DNEL) Maximum amount of substance (mg) –Pr. bodyweigth –Pr. day where no toxic effect is observed DNEL is found in SDS Assumption: –100% bio-availability and uptake –Margin of safety is included in DNEL

Chemical Safety Assessment Hazard Assessment Health/Environmental No classification No PBT or vPvB Exposure assessment Exposure scenario (incl. Risk Reduction Measures) Risk characterisation PNEC/DNEL Classification PBT or vPvB

Risk characterisation RQ = Risk Quotient RQ = RQ > 1: Concern RQ < 1: No concern Hazard Exposure = DNEL: 50 mg/kg/day Specific exposure: 161 mg/kg/day Use is unsafe Modification of exposure scenario RQ > 1

Quantity loaded (kg/day) Level of manual involvement PPE 45 Gloves No gloves Manual Automated Chemical Safety Box Principles Manual No gloves Exposure value (mg/kg/day)

Level of manual involvement PPE 45 Gloves None used Manual Automated To be compared with: DNEL = 50 mg/kg/day Quantity loaded (kg/day) Chemical Safety Box Exposure values

45 Gloves None used Manual Automated 2,1 1,1 0,40,7 0,50,40,2 1,6 1,1 3,2 = Safe = Unsafe Chemical Safety Box Risk Quotients (RQ) Exposure RQ = DNEL =

The complexity of the exposure assessment Loading Exposure scenario n ReceivalFilling  Total systemic exposure = Dermal exposure Oral exposure Inhalatory exposure Dermal exposure Oral exposure Inhalatory exposure …..

Supply chain REACH nøglebegreber Chemical Safety Assessment (CSA)  Chemical Safety Report (CSR) Exposure scenario Exposure assessment Risk characterisation Authorisation Restriction RegistreringEvaluering PRODUCER/ IMPORTER DOWNSTREAM USER SDS SDS (extended) Identified use Conditions for use

Communication Chemical Safety Report (CSR) Part A 1.Summary of Risk Management Measures 2.Declaration that Risk Management Measures are Implemented 3.Declaration that Risk Management Measures are Communicated Part B 1.Identification of the substance and Physical and Chemical properties 2.Classification and Labelling 3.Environmental Fate Properties Part C 1.Human Health Hazard Assessment 2.Human Health Hazard Assessment of Physicochemical Properties 3.Environmental Hazard Assessment 4.PBT and vPvB Assessment 5.Exposure Assesment (Scenario 1, Scenario 2, etc) 6.Risk Characterisation Agency (or kept at site) Chemical Safety Assessment (CSA) to be documented in: Downstream user Annex 1 Exposure scenario 1 Risk reduction measures SDS (1-16) Safety Data sheet (SDS) communication tool in supply chain Extract

Supply chain Communication in supply chain Information on identified use SDS (1-16) Annex 1 Exposure scenario 1 Risk reduction measures Goods SDS (1-16) Annex 1 Exposure scenario 1 Risk reduction measures Goods

Conditions for use Substances Preparations Conditions for use Identified use

a. Vurdering af sikkerhed ved anvendelse af kemikalier Administrativ opgave: Virksomheden har pligt til at udarbejde og medsende sikkerhedsdatablade for de farlige kemiske produkter, som virksomheden sælger til en downstream bruger eller distributør. Sikkerhedsdatabladet behøver ikke laves, hvis produktet udelukkende sælges til forbrugerne. Hvorvidt et kemisk produkt er farligt, skal vurderes i henhold til præparat- direktivet (1999/45/EEC) + “MSDS” direktiv 2001/58

SDS for a preparation - Valid legislation Substances with a classification Classification limit 1,0 (wt%) SDS SDS on request No SDS Substances with a workplace exposure limit 0.1 wt% SDS on request No SDS 1,0 (wt%)

Extended SDS When will we receive this? Substance A Preparation Article Annex SDS (1-16) If substance A is: -On Annex 1 -Has a production volume > 10 t/y -Has been registered Annex SDS (1-16)

Extended SDS for a preparation (REACH) RELEVANT Exposure scenarios Annex SDS (1-16) Substances Substance Annex SDS (1-16) Preparation Article Annex SDS (1-16) Annex SDS (1-16)

Extended SDS for a preparation (REACH) RELEVANT Exposure scenarios Annex SDS (1-16) Substance Annex SDS (1-16) Annex SDS (1-16) Annex SDS (1-16) Substances Preparation Article

Identified use Identified use Annex SDS (1-16) Substances Preparation Annex SDS (1-16)

Extended SDS for a preparation (REACH) RELEVANT Exposure scenarios Annex SDS (1-16) Substance Annex SDS (1-16) Annex SDS (1-16) Annex SDS (1-16) Substances Preparation Article

SDS - Updating requirements The Safety Data Sheet shall be updated on the following occasions: When new data becomes available When a substance has been registered When a substance has been granted or refused for authorisation When a substance has been imposed for restriction

Annex SDS (1-16) Complexity of communication - Identified use Preparation Agent 1 Preparation Substance I.U. A (Reg. 2009) I.U.: Identified use Annex SDS (1-16) A Annex SDS (1-16) A Agent 2 I.U. PreparationSubstance (Reg. 2017) SDS (1-16) A A A

a. Vurdering af sikkerhed ved anvendelse af kemikalier Administrativ opgave: Kemikaliesikkerhedsrapporten skal ikke sendes videre i leverandørkæden som et selvstændigt dokument, men indholdet af den skal være afspejlet i det sikkerhedsdatablad, som skal følge det kemiske produkt. Herudover skal de dele af sikkerhedsrapporten som omfatter eksponeringsvurderinger indgå som bilag til sikkerhedsdatabladet. Kemikaliesikkerhedsrapporten skal løbende opdateres og opbevares, så den er tilgængelig for myndigheder i forbindelse med kontrol og evaluering af stoffet.

b. Anmeldelse af kemikaliets anvendelse Administrativ opgave: Hvis virksomhedens anvendelse af kemikaliet ikke er omfattet af beskrivelse i leverandørens sikkerheds- datablad, eller hvis virksomheden gennemfører eller anbefaler tiltag til at begrænse risikoen, som adskiller sig fra de af leverandøren anbefalede, så har virksomheden pligt til at informere Agenturet.

Identified use Identified use Annex SDS (1-16) X X CSA/CSR Annex SDS (1-16) AGENCY NOTIFICATION AGENCY Substances Preparation

Notification to the Agency Downstream user ID Registration number(s) Substance ID M/I ID, if known Brief description of use Testing proposals if any AGENCY

Chemical Safety Report (CSR) When can we avoid this? Substance A Annex SDS (1-16) Annex SDS (1-16) Substance Preparation Article “Bagatel” limit SDS (1-16) “Bagatel” limit

c. Anvendelse af kemiske stoffer under godkendelsesordningen Administrativ opgave: Hvis en virksomheden anvender et kemisk stof omfattet af godkendelsesordningen, skal virksomheden undersøge om der allerede er givet tilladelse til den anvendelse som virksomheden ønsker at bruge stoffet til.

c. Anvendelse af kemiske stoffer under godkendelsesordningen Administrativ opgave: -Hvis der allerede er givet tilladelse til anvendelsen, skal godkendelsesnumret være angivet på etiketten. Virksomheden skal sende en anmeldelse til agenturet på en særlig blanket, om at stoffet også bruges af denne virksomhed. -Hvis der ikke er givet tilladelse til den anvendelse som en virksomhed ønsker at bruge stoffet til, skal virksomheden ansøge Agenturet om godkendelse til at bruge stoffet

When to act according to Authorisation CMR 1+2 PBT, vPvB, endocrine dis. No action Class. limit 0.1 wt% Check if use of substance is in Annex XIII NOTIFICATION YES APPLICATION NO

Use of authorised substance NOTIFICATION TO AGENCY (no info on which data to be notified!!) within 3 month of first supply

When to act according to Authorisation CMR 1+2 PBT, vPvB, endocrine dis. No action Class. limit 0.1 wt% Check if use of substance is in Annex XIII NOTIFICATION APPLICATION YESNO

Application for Authorisation (manufactor, importer, downstream user) 1.Identity of the substance 2.Name and contact details of the person 3.Request for authorisation, specifying use 4.Chemical Safety Report May include: a.Socio-economic analysis b.Analysis of the alternatives, incl. substitution plan

Authorisation – granting (manufactor, importer, downstream user) Applicant(s) Preparations Application Total estimated time approx. 18 months AGENCY 3rd part hearing WWW Draft Decision EU COM Substances Article EU Importer

IKKE INDKLUDERET I Erhvervs og Selskabsstyrelsens projekt

FDLF´s REACH høringssvar På grund af begrænset gennemsigtighed i vores del af forsyningskæden kan REACH blive vanskelig at håndtere i praksis Et ukendt antal råvarer forventes at forsvinde – nogle fordi registreringen af stofferne ikke vil være rentabel Utilstrækkelig beskyttelse af fortrolige data SDS mareridt fordi opdatering forventes at ske øjeblikkelig, f.eks. efter at et givet stof har fået tildelt et registreringsnummer Umiddelbart er den kommende globale harmonisering af klassifikation og mærkningssystemet for kemiske stoffer og produkter (GHS) ikke indarbejdet i REACH Mistet konkurrenceevne, idet varer, der importeres udenfor EU, vil kunne produceres billigere, da de ikke er underlagt samme registreringsomkostninger Forordningen giver den kemikalie-producerende industri (råvareleverandører) undtagelser fra registreringsproceduren i forbindelse med forskning og udvikling af nye produkter og processer – samme undtagelse findes ikke for den kemisk-forarbejdende industri (Downstream Usere)