Meeting of the Fertilizers' Working Group and Regulatory Committee16 March 2015Centre Albert Brochette, Brussels

Katrin SchutteDG ENVIRONMENT, Chemicals Unit A3

Objective: Provide REACH registration context for secondary raw materials

Content: - presentation of the registration procedure - exemptions: compost + status of digestate - UVCB - Importance of the compliance to end of waste

criteria for substance sourced from waste prior to registration within REACH

REACH aim: protect human health and the environment

against potentially dangerous chemicals by creating a “clean” EU by ~2018

B.Risk management: No concern :OK to continue manuf./import and use

Ban of CMR 1&2, PBT, vPvB and Endocrine Disr. unless proven safe for a certain use (Authorization)

Restriction of chemicals of concern via risk management measures taken in REACH or other downstream legislation’s e.g. Cosmetic, Water, Air, Working protection in plants etc…

A. Data Collection, C&L and Risk Assessment

To be replaced by safer substances= Substitution principle

Pre-registrationRegistration / Evaluation

All Substances

>1t/y/manuf. or importer

REACH elements:

Environment

Registration (Title II): all substances ≥ 1 tonne/year

Evaluation (Title VI): of some substances by the European Chemicals Agency

Authorisation (Title VII): for substances of very high concern

Restrictions (Title VIII): when there is an unacceptable risk arising from the manufacture, use or placing on the market

REACH elements:

Environment

Registration: all substances ≥ 1 tonne/year

Evaluation of some substances by the European Chemicals Agency

Authorisation for substances of very high concern

Restrictions when there is an unacceptable risk arising from the manufacture, use or placing on the market

REACH generating knowledge[1]

Environment

Registration: Chemical Safety Report (CSR) with a Chemical Safety Assessment (CSA) ( … for all substances above 10 tonnes/year)

Exposure Scenarios (ES)(… to demonstrate that the risks from exposure during substance manufacture and use are controlled when specific operational conditions (OC) and risk management measures (RMM) are applied)

Derived No Effect Levels – DNELs (… for most registered substances ~12.500)

REACH generating knowledge[2]

Environment

DNELs are based on hazard informationderived for all relevant routes of exposure

(… inhalation – dermal – and/or oral routes)

DMELs:

Derived Minimum Effect Levelsfor substances where no safe threshold can be set (e.g. carcinogenicity)

REACH registration

• Substances > 1000 t/yr : deadline Dec 2010 4 300 substances in nearly 25 000 dossiers

• Substances > 100 t/yr : deadline June 2013 2 998 substances

• Substances : > 1 – 10 and > 10 t/yr : deadline 2018

• ~ 20 000 substances expected

Registration principles

• - Same substances to be registered together in joint dossier to limit testing

1. - Sharing of data via SIEF (Substance Information • Exchange Fora)

Importance of Substance Identity (SID) to determine Sameness – Joint dossier

• CAS no. SIEF

Substance sameness….

Sharing of all data

Sharing of data – with opt-out(s)

Different substances – Two registrations

Separate set of data – with read-across

Separate set of data – No read-across

Same substance – One registration

Frontier for sharing test results - “Hazard profile sameness”

Frontier for Joint registration - “REACH regulatory substance sameness”

Decreasing degree of Substance sameness

What’s the right distance? i.e. Nature and number of opt-out leading to separate registrations? (recital 45)

Relevance for: - TP - CCH - Substance evaluation - AXV SVHC - AVI CLH - CL notifications

Relevance for: - Joint submission - Inquiry

Substance sameness…• Article 117(2) report:

• “The principles that companies should follow when concluding on substance sameness should be clarified. The Commission is invited to consider issuing implementing legislation to REACH which would also ensure that substances of significantly different composition are not merged into single dossiers.”

•

Clarification of the concept is needed• Most critically for UVCBs• For well-defined substances guidance is sufficient

(of all registered substances, 85% are well-defined and 15% are UVCB substances)

• Timeline• clarification needed for 2018 (ECHA)

UVCBs

• Unknown (fraction of) composition • e.g. Petroleum, plant extracts

• Variable composition• uncontrolled e.g. catalyst life span leading to different

compositions over time (e.g. regio-isomers)• controlled e.g. substances manufactured according to

(variable) customer specifications (e.g. isopropylated triphenyl phosphate)

• Complex reaction products• =high number of constituents

• Biological materials• potentially U, V and C together – or none of them! e.g. fatty

acid derivatives

UVCBs – initial ideas

• REACH recital 45 (in reverse?)• EINECS included certain complex substances in a single entry. UVCB

substances may be registered as a single substance under this Regulation, despite their variable composition, provided that the hazardous properties do not differ significantly and warrant the same classification.

• A UVCB substance may be registered as a single substance despite (significant) variations in composition, provided unicity of hazard profile/classification.

• A UVCB substance with (significant) variations in composition may not be registered as a single substance if it shows different hazard profiles/classifications.

UVCBs – ECHA work in progress• Based on EINECS reporting rules for UVCBs • Six methods for depicting UVCBs:• 1. Structural representation• 2. Reaction scheme

• Identity of the immediate precursors• Identity of the reactants

• Reaction type• 3. Process description

• Precursors• Technology (method of preparation; process terms)• Typical composition

• 5. Combination of the abovementioned methods

Exemptions from Title II Registration

- REACH Art. 2 (2): Waste as defined in DIR 2006/12/EC

- REACH Art. 2(7): "Substances covered by Annex V as registration is deemed inappropriate or unnecessary for these substances…."ANNEX V: - Substances which occur in nature, if not chemically modified: minerals, natural gas, crude oil- Other substances occurring in nature unless classified as hazardous- Compost and biogas

Examples of secondary RMs: compost & digestate

• Digestate is the fully fermented, mostly liquid remain of a fermentation process. It is generated during operation of biogas plants, in addition to the biogas itself. If the decomposition process of biomass (biogenic organic materials) occurs with aerial supply (aerobic conditions), one speaks of composting; the generated products are compost, heat and a CO2-rich gas. If this process occurs without such a supply (anaerobic condition), one speaks of digestion; the generated products are: nutrient rich digestate, and a high-energy methane-containing gas mixture - the biogas.

Biomass

aerobic anaerobic

compost

CO2 rich gas + heat

digestate

Biogas (contains methane)

Digestate: waste or not waste ? • - Waste (as per DIR 2006/12/EC) is exempted

from REACH as per Article 2(2)

• - Is Digestate waste ? It depends:• It ceases to be waste once it has reached the End of

Waste criteria : no EU criteria yet, only MS level, some do some don't consider as waste

• When it is waste -> exempted from REACH• If it isn't waste -> in principle still subject to REACH

• In absence of EU harmonised End-of-Waste criteria for digestate and compost, it is up to MS authorities to define if and under what conditions these materials can leave the waste status and enter the product stage.

©Thinkstock

REACH Annex V exemptions• - A naturally occurring substance

(entries 7 and 8)?Definition of naturally occurring substances in Article 3(39) + ECHA guidance

"It should be noted that whole living or unprocessed dead organisms (e.g. yeast […] freeze-dried bacteria) or parts thereof (e.g. body parts, blood, branches, leaves, flowers etc.) are not considered as substances, preparations [mixtures] or articles in the sense of REACH and are therefore outside of the scope of REACH. The latter would also be the case if these have undergone digestion or decomposition resulting in waste as defined in Directive 2008/98/EC, even if, under certain circumstances, these might be seen as non-waste recovered materials"

©Thinkstock

• - Entry 12 ? Entry 12 only covers specifically compost (the aerobic fermentation product) and biogas – the result of anaerobic digestion - but not digestate which although similar is not specifically exempted

Annex V entries

• - 2008 : review of Annex V was up for Committee vote and discussion on digestate came late in the process

• - due to lack information it had been impossible at the time to assess whether digestate should be exempted as well

• - it was considered that compost and digestate were different (aerobic/anaearobic) and exemption of one did not automatically mean exemption of the other

• - but the result is that biogas is exempted but the situation of digestate is not clear from the text of the relevant entries

©Thinkstock

Next steps • - COM is open to address a broadening of Annex V Entry 12 to also cover digestate (as discussed at CARACAL 16, Nov 2014)

• - Amendment of Annex V to coincide with CLP alignments

• - Based on the above, the discussions will be in principle limited to digestate©Thinkstock

• Thank you !