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The substitution principle in European legislation
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Programme
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Conference Betriber&Emwelt
Introduction
26 June 2014 – Luxembourg
Dr. Ruth Moeller (ERT)
REACH&CLP Helpdesk Luxembourg
The SVHC Roadmap 2020
Commitment of the EU Commission 2010:
“have all relevant currently known SVHCs included in
the candidate list by 2020“
“REACH2020”
authorisation obligation and substitution of the most severe
hazardous substances
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Substitution of hazardous chemicals
Working Definition
“The replacement or reduction of hazardous substances
in products and processes by less hazardous or nonhazardous substances, or achieving an equivalent
functionality via technological or organisational
measures.”
Lohse, Lissner (2003): Substitution of Hazardous chemicals in products and processes. Report compiled for Directorate General for Environment of the
European Commission
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Substitution of hazardous chemicals
Risk Reduction
Risk = Exposure / Hazard
Hazard
replace or reduce hazardous
substances in products and
processes
Exposure
reduce or eliminate emissions
by setting technical or
organisational barriers
Substitution is a (preferred) way of eliminating
or reducing the risk from chemicals
to health, safety and the environment
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Substitution of hazardous chemicals
Players
Policy
makers
Pressure
groups
Company
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Substitution of hazardous chemicals
Company
Safety
Internal units and supply chain
 Implementing substitution – dayto-day risk management
 Complexity: re-formulation vs.
innovation
Availability
alternative
Economic
feasibility
Societal
interest
Guarantee
liability
Communication
Legislation
Norms
Available
resources
Technical
functionality
Risk
HH / ENV
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Substitution of hazardous chemicals –
regulation-driven innovation
Substitution of hazardous chemicals
Policy
makers
Legislation (Hard law):
 Obligatory: unspecified
or strict obligations
 Legislation promoting
substitution
Financial incentives:
 Taxes
 Fees
Governmental
authorities
 Setting framework
via legislation
 Compromise:
Protection, technical
feasibility and
economic viability
Soft law:
 Voluntary commitments
and agreements
between parties
 Awards, labels, …
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The substitution principle in European legislation
Information and Tools on
sustainable chemicals
management and
regulation:
 Campaigns and
trainings
 Portals, guides,
databases
RDI promotion:
 Cluster initiatives
 Networks
 Funding
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The substitution principle in European
legislation
26 June 2014 – Luxembourg
Dr. Ruth Moeller (ERT)
REACH&CLP Helpdesk Luxembourg
Content
The substitution principle in European legislation
Dr. Ruth Moeller (REACH&CLP Helpdesk LU):
 Introduction
 CLP Regulation
 Occupational Health
 Pesticides
Dr. Ledrich (Luxcontrol):
 Biocide
 Volatile Organic Compounds
 EEE, End-of-Life Vehicles, Batteries and Accumulators
Dr. Arno P. Biwer (REACH&CLP Helpdesk LU):
 REACH Regulation: Restriction and Authorisation
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The substitution principle in European
legislation
Principles of European Chemicals policy
 Precautionary principle
 Industry responsibility to not place hazardous substances on the market that
adversely affect human health or the environment
Aim




High level of protection of human health and the environment
Sustainable development
Efficient functioning of the internal market
Competitiveness & innovation of European Industry
Harmonised driver for
substitution in several
pieces of European
chemicals legislation
Picture: European Commission
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The substitution principle in European
legislation
Chemicals legislation
REACH
CLP
Environmental
legislation
Biocides
Pesticides
Detergents
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Occupational
Health
Chemical
Agents,
Carcinogens and
Mutagens, …
UN convention
implementing instruments:
POP, Ozone
Consumer and
sector-specific
legislation
Specific limitations
(VOC),
OSPAR,
IED, Waste (ELV,
Batteries, WEEE), WFD,..
…
General Product
Safety, Cosmetic,
Food, EEE, Toys, ...
The substitution principle in European legislation
Control of
major
accidents
Seveso
Transport
and
International
Trade
PIC, ADR
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The substitution principle in European
legislation
What is “hazardous”?
 Hazard: “Inherent property of an agent or situation having the potential to cause
adverse effects when an organism, system or (sub)population is exposed to that
agent” (IPCS, 2004)
 Legal definition: Regulation (EC) No 1272/2008 on classification, labelling and
packaging of substances and mixtures (CLP): hazard class, hazard category,
and hazard criteria
 No harmonised criteria for persistent and bioaccumulative properties (PBT, vPvB)
and endocrine disruption (ED) – harmonisation on-going!
 What makes a chemical a “substance of concern”?
 Legally binding criteria defined by various pieces of legislation: CLP
classification and further criteria
 Severe intrinsic properties: CMR (carcinogenicity, mutagenicity, toxic to
reproduction), PBT / vPvB, ED, (respiratory) sensitisers, STOT, …
STOT = Specific Target Organ Toxicity
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The substitution principle in European
legislation
CLP:
Regulation (EC) No 1272/2008 on Classification,
Labelling and Packaging of substances and mixtures
http://ec.europa.eu/environment/chemicals/labelling/index_en.htm
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CLP Regulation
Regulation (EC) No 1272/2008 on Classification,
Labelling and Packaging of substances and mixtures
 Entry into force 20 Jan 2009
 Competent authority: Ministère du Développement Durable et des Infrastructures
(MDDI) supported by the Administration de l’environnement (AEV)
Scope
 Implementing the UN Globally Harmonised System (GHS)
on classification and labelling (C&L) in the EU
 Chemical substances and mixtures (exemptions see Art. 1 CLP)
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CLP Regulation
Relevance for substitution
 C&L provides incentive for voluntary substitution due to supply chain
communication of hazardous properties via the label: Informed choices of
downstream users and consumers
 Harmonised classification triggers obligatory substitution provisions in
downstream legislation
 Various legislation and international conventions are linked to CLP and rely on
classification: “Downstream legislation”, e.g. Biocides and Plant Protection
Products Regulations are “customers” of CLP
Carcinogens
and Mutagens
Directive
FCM = Food Contact Materials
RoHS = Directive on the restriction of the use of
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certain hazardous substances in electrical and
electronic equipment
DOWNSTREAM
legislation
The substitution principle in European legislation
CLP
BIOCIDES
REACH
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CLP Regulation
Harmonised Classification and Labelling (CLH)
 Ensure adequate risk management in the Community
 Mandatory for suppliers
 What: Substances being carcinogenic, mutagenic, toxic to reproduction (CMR
Cat 1A, 1B, 2) or a respiratory sensitiser (Cat 1); active substances of biocidal
and plant protection products; if classification at EU level is needed (case-bycase)
 4509 substances with CLH currently: http://www.echa.europa.eu/informationon-chemicals/cl-inventory
 Currently approx. 70% of CLH dossiers in opinion development concerns active
substances of biocidal and plant protection products
ECHA Notification
Proposal Submission
Intention Publication
by Member State
~ 2 months - 2 years
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RAC opinion
+ 18 max. months
The substitution principle in European legislation
COM Decision
3-5
years
without undue delay
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CLP Regulation
www.phthalate-frei.de
CLH – Example
Phthalates


Mainly used as plasticizers (or softeners) in plastics, especially in flexible PVC
Some: Classification as toxic to reproduction (Repr. 1B)
Restriction toys and childcare articles
Use prohibition cosmetics
Occupational Health RMM
CLH
Repr. 1B
National voluntary action plans for phase-out and OELs
e.g. Bis(2ethylhexyl)
phthalate
(DEHP)
CAS#
117-81-7
REACH Restriction: no supply to the general public
Priority substance with EQS in Water Framework Directive 2008
SVHC (REACH
Art 57c) 2008
Annex XIV authorisation obligation
(Sunset Date 2015)
Food Contact Material: restriction for DEHP additive and a
phthalate group (concentration/type of material, 2011/2009)
COM recommendation for RoHS restriction 2014
OEL = Occupational Exposure Limit
EQS = Environmental Quality Standard
The substitution principle in European legislation
SVHC = Substance of Very High Concern
RoHS = Restriction of hazardous substances in electrical and electronic equipment
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The substitution principle in European
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Occupational Health
OSH “Framework Directive”: Directive 89/391/EC on Safety
and Health at Work
Chemical Agents: Directive 98/24/EC on the protection of the
health and safety of workers from the risks related to chemical
agents at work
Carcinogens and Mutagens: Directive 2004/37/EC on the
protection of workers from the risks related to exposure to
carcinogens or mutagens at work
https://osha.europa.eu/en/legislation/directives/exposure-to-chemical-agents-and-chemical-safety
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Occupational Health
Main current legislations in Luxembourg
 Règlement grand-ducal du 30 juillet 2002 concernant la protection de la santé et de
la sécurité des travailleurs contre les risques liés à des agents chimiques sur le lieu
de travail, and amendements (Règlement grand-ducal du 19/11/2011 et Règlement
grand ducal du 28/07/2011)
 Règlement grand-ducal du 30 juillet 2002 concernant la protection des travailleurs
contre les risques liés à l'exposition à des agents cancérigènes ou mutagènes au
travail.
 La loi modifiée du 14 décembre 2001 sur les services de santé au travail: requires
every employer to do « un inventaire des postes à risque »
 More information: www.legilux.public.lu
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Occupational Health
Relevance for substitution


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


The employer must determine whether any hazardous chemical agents are present
at the workplace and assess any risk to the safety and health arising from their
presence
The employer shall ensure that the risk from a hazardous chemical agent to the
safety and health of workers at work is eliminated or reduced to a minimum (…)
The employer shall assess and manage the risk of exposure to carcinogens or
mutagens: Carcinogen / mutagen (C/M): Substance/mixture classified Cat 1A/1B acc.
CLP
The employer shall reduce the use of a carcinogen or mutagen at the place of
work, in particular by replacing it, in so far as is technically possible (…)
Substitution as protective and prevention measure at the workplace
 Priority hazardous chemical agents: 1. Substitution, 2. minimise release
by RMM, 3. collective protection measures at source, 4. individual protection
measures
 Priority C/M 1. Substitution, 2. closed system, 3. reduce exposure level
For C/M: No socio-economic considerations – if technical possible!
RMM = Risk Management Measure
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Occupational Health
Support information: Health and safety at work (ec.europa.eu)
high
Substitution
Inventory
of
chemicals
used at
workplace
Risk
assessment
and
inventory of
hazardous
jobs
“Watch list”
of
substances
of concern
P
R
I
O
R
I
T
Y
Analyse
alternatives
and
technical
feasibility of
substitution
Anticipation
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Minimise
Release
Priority
Implement RMM
Collective
protection measure
Individual protection
measure
low
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The substitution principle in European
legislation
Plant Protection Products (PPPR)
Regulation (EC) No 1107/2009 concerning the placing
of plant protection products on the market
http://ec.europa.eu/sanco_pesticides/public/?event=homepage
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Plant Protection Products Regulation
(PPPR)
Regulation (EC) No 1107/2009 concerning the placing
of Plant Protection Products on the market
 Entry into Force 14 June 2011
 EU Authority: European Food and Safety Authority (EFSA)
 Luxembourg: only text which transposed former Directive:
 Loi modifiée du 20 février 1968 ayant pour objet le contrôle des pesticides et des
produits phyto-pharmaceutiques;
 Règlement grand-ducal du 14 décembre 1994 concernant la mise sur le marché des
produits phytopharmaceutiques and its ammendments.
 Competent Authority: Ministère de l’Agriculture, de la Viticulture et de la Protection des
consommateurs supported by l’ Administration des services techniques de l’Agriculture
Scope
 Protecting plants or plant products against all harmful organisms or preventing
the action of such organisms, influencing the life processes of plants, preserving
plant products, destroying undesired plants or parts of plants, checking or
preventing undesired growth of plants.
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Plant Protection Products Regulation
(PPPR)
Relevance for substitution
 Stringent two-step approval procedure for active substances (a.s.), safener,
synergists ensuring high level of protection
 Very strict approval criteria for a.s.: Only, amongst other like efficacy, if no
unacceptable effects on human health or environment
 Candidates for Substitution (CfS) and comparative assessment of plant
protection products
 Derogation rules promoting low-risk substances
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Plant Protection Products Regulation
(PPPR)
Approval criteria
Active substance
EU Authorisation
Approval
criteria not met
Cut-Off
Approval
Criteria
met
Annex I Inclusion
Authorisation
Assessment:
National,
mutual
Low risk
recognition, substances?
zonal
Product
authorisation
?
Non-Inclusion
(hazard)
 Acceptable risk
 Hazard based cut-off
criteria: CMR Cat 1A/1B,
ED, POP, PBT/vPvB,
honey bee tox
Substitution criteria
Candidate for (hazard & risk)
 Approved CR, ED
Substitution  2 PBT criteria
 Concern due to critical
effects
Comparative assessment Lower reference values
 High portion non-active
use-by-use
isomers
country-by-country
National
authorisation
ED = Endocrine Disruption,
POP = Persistent Organic Pollutants, CMR= carcinogenic, mutagenic, toxic to reproduction
PBT/vPvB = persistent, bioaccumulative, toxic / very persistent and very bioaccumulative,
No national
authorisation
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Plant Protection Products Regulation
(PPPR)
Potential impact for companies



Companies: manufacturer, suppliers and (professional) users
Impact on costs due to stricter assessment and authorisation rules
Product availability on national market
 Strict cut-off criteria and risk assessment procedures may impact a.s. approval
at Union level
 CfS: impact difficult to predict (will not leave EU market)
Use
country
vineyards
tomato
FR
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…
x
DE
…
wheet
x
?
x
x
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Thank you for your attention!