Technical report 125

APPENDIX C: SUMMARY OF EU ENVIRONMENTAL LEGISLATION AND CONVENTIONS WITH ECOLOGICAL PROTECTION GOALS RELATING TO CHEMICALS

 

European Legislation

International Agreement

Registration Evaluation Authorisation and
restriction of Chemicals (REACH) Regulation
(EC 1907/2006)

Plant Protection Products Regulation (PPPR)
(EC 1107/2009)

Biocidal Products Regulation (BPR)
(EU 528/2012)

Medicinal Products for Human Use Directive (MPHU)

(2001/83/EC)

Medicinal Products for Veterinary Use
Directive (MPVU)
(2009/9/EC)

Strategic Approach to International Chemicals
Management
(SAICM, 2006)

High-level protection goals

Protect
human (and animal [PPPR, BPR]) health and the environment via the
Precautionary Principle


Prevent undesirable environmental effects due to the use and/or disposal of
human (MPHU) / veterinary (MPVU) medicinal products


Assess environmental impacts for all new marketing authorisations,
indications and extensions

Manage
chemicals to minimise significant adverse human health and environmental
effects by 2020

No
significant adverse effects in any environmental compartment

No
unacceptable environmental effects, including impacts on biodiversity and
the ecosystem

Chemical protection goals (incl. chemical contamination in biota /
food chains)

Chemical hazard:

(a)
human; (b) physicochemical; (c) environmental; d)
Persistent, bioaccumulative and toxic (PBT) and very persistent and very
bioaccumulative (vPvB)


Apply restrictions


Substitute higher risk substances with lower risk alternatives

Chemical hazard:


Screen active pharmaceutical ingredients (APIs) with Log Kow
>4.5 for PBT

Chemical hazard:

(see MPHU)


(see PPPR, BPR)


Extra requirements for products containing genetically modified organisms


Prevent use of high risk chemicals by 2020


Minimise release of high risk chemicals by 2020


Reduce hazardous waste generation, and ensure green hazardous waste
management


Substitute high risk chemicals with lower risk alternatives


Risk assessment and exposure mitigation
of active substances (incl. micro-organisms [BPR]), relevant major
metabolites (³10% of parent and/or with comparable toxicity to parent
compound), formulated products


Maximum residue limits set for food (treated animals and excreta [MPVU]),
soil and groundwater

Ecological protection goals

No
significant adverse effects on ecological populations, food chains and
communities

No
unacceptable effects in non-target species (PPPR, MPVU) / any compartment
(BPR, MPHU); surface waters, groundwater, soil, air (PPPR, MPVU), sewage
treatment plants (BPR, MPHU
), excreta (MPVU)

Protect
vulnerable ecosystems in decision making

Ecological entities considered

Non target
organisms
(aquatic and terrestrial); plants,
invertebrates (incl. dung organisms [MPVU]), vertebrates, soil
micro-organisms
(PPPR, BPR, MPVU), microbiological activity of
sewage treatment plants
(REACH, MPHU)

Represents
relevant exposed compartments

Target
organisms (plant products)

Target
organisms

(see REACH column)

Target
organisms (animals)

(see REACH column)

Assessment criteria (critical attributes) identified for
ecological entities

Direct effects:


Survival, growth, development, reproductive success, function (microbial
activity, respiration, biodegradability)

Direct effects:

Non-target
species acute or chronic effects, incl.


survival and development


harmful effects on animal health


behavioural effects

Direct effects:

(see REACH column)

Indirect effects: Secondary poisoning via the food chain (all); evolution of
resistance incl. anti-microbial resistance (BPR, MPHU, MPVU)

Assessment endpoints / indicators (measured / monitored)

Risk
Characterisation Ratio compares predicted environmental concentration (PEC)
with generic, multi -species and -trophic level predicted no effect
concentration (PNEC) (see EU TGD)

Toxicity
Exposure Ratios compare predicted exposure concentration with effect
concentrations for a range specific endpoints spanning microbe function
(e.g. nitrogen cycling) to individual health parameters (e.g. birdÕs egg
shell thickness)

Risk
Characterisation Ratio compares predicted environmental concentration (PEC)
with generic, multi -species and -trophic level predicted no effect
concentration (PNEC) (see EU TGD)

Assessment
endpoints are stipulated in approved test guidelines referred to in the EU
Technical Guidance Document (TGD) and sector-specific guidance

Indicator targets / thresholds for acceptable versus unacceptable
effects or status

Adopt
ecological threshold principle in EU Technical Guidance – use PEC/PNEC <1

Community
recovery principle

Retrospective
risk assessment via: information on adverse environmental effects (BPR);
eco-pharmacovigilance (MPHU) (see Pharmacovigilance Regulation EU
1235/2010)

 

Table C1.2: Legislation and
conventions focusing on chemicals and requiring prospective ERA and/or
retrospective environmental surveillance, monitoring and impact assessment

 

European Legislation

International Convention

Environmental Liability Directive (ELD)
(2004/35/CE)

Control of Major Accident Hazard Directive
(COMAH) (2012/18/EU)

Sewage Sludge Application Directive (SSAD)
(86/278/EEC)

Air Quality Framework Directive (AQFD)
(2008/50/EC)

Groundwater Protection Directive (GPD)
(2006/118/EC)

Environmental Quality Standards Directive
(EQSD)
(2008/105/EC)

Industrial
Emissions Directive (IED)
(2010/75/EU)

European Pollutant Release and Transfer
Register (E-PRTR) Regulation (EC 166/2006)

Thematic Soil Strategy (TSS)
COM/2006/0231
COM/2006/0232

Stockholm Convention
(SC, 2001)

High-level protection goals

Prevent (and remedy):

Environmental
damage (ÔPolluter paysÕ principle) (ELD); major accidents
(‘Precautionary principleÕ) (COMAH); human health and environmental
hazards associated with sewage sludge; soil and agricultural product quality impairment
(SSAD)

Protect
human health and the environment as a whole


Reduce priority substance pollution


Protect human health and the environment as a whole


Remedy environmental damage


Provide public access to information on pollutant releases and off-site
transfers, and track trends


Protect soil and sustainable use


Preserve soil functions


Manage soil use and risks


Protect human health and the environment from Persistent Organic Pollutants
(POPs)


Combat atmospheric emissions at source


Set ambient air quality objectives

Prevent, reduce and/or remediate (via
the ÔPrecautionaryÕ and ÔPolluter paysÕ principles)
:

Deterioration
and chemical pollution of groundwater (GPD); environmental damage at
source from priority hazardous substance emissions (EQSD); industrial
pollution (IED); pollution and human health impacts (E-PRTR),
soil degradation (TSS), harmful impacts of POPs, including
transboundary impacts requiring international cooperation, conciliation and
funding (SC)

Chemical protection goals (focusing on chemical contamination in
biota / food chains)

Prevent
and/or remedy release of Classification Labelling and Packaging Regulation
(CLPR) (EC 1272/2008) and COMAH listed dangerous substances

Set
limit values for listed substances

Maintain
good groundwater chemical status via:


Limiting pollutant input


Preventing listed (WFD, CLPR, PPPR, BPR) hazardous substance input


Set Environmental Quality Standards (EQSs) for priority substances and
priority hazardous substances

Integrated approach:


Set industry emission limit values (ELVs)

– Adopt best available techniques (BAT)

Threshold
pollutant release values (loads) for reporting


Address soil contamination at source


Identify, monitor and remediate historically contaminated sites (via ELD)


Eliminate production / use and properly dispose / remediate POPs
listed in Annex A


Minimise (using BAT) exposure from production and use of POPs in Annex B
& C

Minimum
periods following sludge application before use of pasture or harvesting of
crops

Set
critical values which may directly affect some receptors, but not humans

Prevent
and/or remedy release of: listed (WFD, CLPR, PPPR, BPR) hazardous substances

Ecological protection goals

No
adverse impact of:


Biodiversity: Natural
habitats and protected species


Water: Ecological quality
or potential
.


Land: natural resources
and services
affecting human health

Avoid
permanent or long-term damage to:

– Terrestrial habitats

– Freshwater habitats

– Marine habitats


Groundwater

Prevent
contamination of:


Agricultural crops


Livestock

Avoid,
prevent or reduce harmful effects on:


Vegetation


Natural ecosystems

Conserve
groundwater quantity, chemical quality, and dependent ecosystems

Prevent
chemicals from causing:


Acute and chronic aquatic toxicity


Accumulation in the ecosystem


Habitat and biodiversity loss


Threats to human health

Report:

Direct
emissions into:


Air


Water

Indirect
emissions into land

Report releases into:


Air


Water


Land


Protect soil structure and function (incl. ecosystem services)

Prevent
adverse effects to human health and the environment, incl. from toxicological
interactions involving multiple chemicals

Ecological entities considered

Listed
protected species and natural habitats (ELD: biodiversity; COMAH: terrestrial)


Agricultural crops


Livestock


Vegetation


Natural ecosystems

Groundwater:


As a resource


Ecosystems


Dependent ecosystems


River basin management plans limited to WFD

Aquatic
biota

None
specified

None
specified

Soil
associated ecosystem services

Humans:
Arctic indigenous communities, pregnant women.

Arctic
eco-systems: incl. top predators (due to biomagnification)

WFD
(Annex V) listed biological quality elements

Land: resources and services unspecified

Agricultural
habitats

Assessment criteria (critical attributes)
identified for ecological entities

Biodiversity

Long-term maintenance of:

– Distribution/area
– Structure
– Habitat function
– Survival
– Species density

Water: See WFD Annex V

Land: See ELD Annex 1

– (See ELD column)

– See domestic guidance within Member States
(MSs)

Chemical concentrations and loads in; soil (SSAD),
air (AQFD), groundwater (GPD)

Chemical criteria in:

– Water (primarily)
– Sediment
– Biota

– ELVs for water and air

– Baselines for monitoring

– Soil and

– Groundwater contamination

Chemical (loads) for releases to:

– Air
– Water
– Land

Long-term maintenance of soil:

– Structure
– Function

– Bioconcentration / accumulation factors
(measured or predicted using Log Kow)

– Reproductive health

 

Groundwater
quantity criteria

Assessment indicators measured / monitored


Number of individuals


Density / area


Roles of natural resources affected


Species / habitat rarity (local to regional level)


Population dynamics


Human health impacts

Chemicals
only (see Annexes 1A, 1B and 1C [SSAD]; Annexes II & XIII [AQFD])

Chemicals
and conductivity in groundwater (GPD), water (EQSD) (see
Annexes I & II)

Chemicals
only (polluting substances listed in Annex II)

Indicators
likely linked to main threats


Presence, levels and trends in humans and environment
– Transport, fate transformation
– Effects on human health and environment (including reproductive health)


Chemicals in biota
(see Article 3)

Indicator targets / thresholds for acceptable vs unacceptable
effects or status

Effects
assessed against Ôbaseline conditionÕ, considering:


ÔFavourable Condition StatusÕ for habitats (HD Article 1)


Natural species and habitat fluctuations


Recovery potential


Significant damage defined in ELD Annex 1


Area and duration of major accidents (COMAH Annex VI)

Chemicals
only (see Annexes 1A, 1B and 1C [SSAD]; Annexes II & XIII [AQFD])

Chemicals
and conductivity in groundwater (see Annexes
I & II)

EQSs
represent:
– Annual averages for long-term exposure protection
– Maximum allowable concentrations for short-term exposure protection

Chemicals
only (see ELVs in Annexes V-VIII [IED]; Annex II [E‑PRTR])

Thresholds
and scope still under development


Persistence threshold (half-life in months) water 2, soil 6, sediment


Bioconcentration / accumulation factor 5000 (or Log Kow 5)


Table C1.3: Legislation and
conventions also affecting chemicals and requiring prospective ERA and/or
retrospective environmental surveillance, monitoring and impact assessment

 

European Legislation

International Conventions

Marine Strategy Framework Directive (MSFD)
(2008/56/EC)

Habitats Directive (HD)
(92/43/EEC)

Birds Directive (BD)
(79/409/EEC)

Water Framework Directive (WFD)
(2000/60/EC)

Convention on Biological Diversity
(CBD) (UN, 1992a)

OSPAR Convention
(OSPAR, 1992)

Bonn Convention on Migratory Species
(CMS, 1979)

Convention on the Law of the Sea
(UNCLOS, 1982)

High-level protection goals

Achieve
Good Environmental

Status
(GES) in marine waters by 2020 (biodiversity descriptors: 1, 2, 4, 6)

Maintain
/ restore natural habitats and species of Community interest to ÔFavourable
Conservation StatusÕ (FCS)

Establish
Natura 2000 Special Areas of Conservation network

Conserve,
protect and manage all wild birds species, and set rules for their
exploitation

Establish
Special Protection Areas (SPAs)

Protect,
enhance and restore all surface water bodies

Achieve
good surface water status by 2015 and 2027

Conserve
biological diversity, ensure sustainable use and fair and equitable sharing
of benefits of genetic resources

Prevent
and eliminate pollution, protect the OSPAR maritime area against adverse
effects of human activities

Conserve
migratory species and their habitats

Agreements
between Range States to conserve species listed in Appendix II

Provide
law and order in the world’s oceans and seas

Protect
and preserve the marine environment and exploit resources in accordance with
this

Prevent,
reduce and control marine pollution

Chemical protection goals (focusing on chemical contamination in
biota / food chains)

Action
at source to avoid pollution

Define
safe levels for human consumption

Prevent
and reduce marine environment inputs

Not
defined

Not
defined

Achieve
good chemical status by 2015 and 2027 (see Sections 1.2 and 2.3)

Not
defined

Reduce
environmental inputs and concentrations of Priority Hazardous Substances.

Prevent
pollution by continuous reduction of discharges.

Not
defined

Prevent,
reduce and control marine pollution

Ecological protection goals

Prevent
significant impacts / risks to marine biodiversity, ecosystems, human health
or legitimate uses of the sea

See
HD FCS assessment criteria targets (see Annex E and EU Guidance
[EC, 2011c])

Maintain
species population levels at ecological, scientific, cultural and economic
requirements

Achieve
good ecological status by 2015 and 2027 (see Annex V and Section 1.2)

2011-2020
Strategic Plan: 20 ÔAichiÕ Biodiversity Targets for 2015 or 2020

Contracting
Parties may set individual targets

Regional
Assessment defines % targets for criteria used in the QSR regional assessment
process (see Tables A2.1 and A3.1 of OSPAR [2009])

Long-term
species viability

No
range reduction

Sufficient
habitat for long-term population maintenance

Not
defined

Ecological status classes

GES

Sub-GES

Favourable

Unfavourable (inadequate/bad)

Not defined

Ecological
status
:

High, Good, Moderate, Poor, Bad

Not defined

Good

Moderate

Poor

Not defined

Not defined

Ecological entities considered

All
EU marine biodiversity (see Annex III, Table 1)

HD
listed Natural habitats and species (see Annexes I, II, IV & V)

All
naturally occurring wild birds species (see Annexes I, II & III)

Biological
quality elements (see Section 1.2.1)

All
biological diversity

All
North-East Atlantic maritime habitats and species

CMS
listed migratory species (see Appendix I and II)

Vulnerable,
rare or declining marine habitats and species (globally)

Migratory
species

Assessment criteria (critical attributes) identified for
ecological entities

See
descriptors: 1, 2, 4 and 6 of 2010/477/EU

Habitat:
– Range, area, structure and function

Species:
– Range, habitat, population size and condition


Population size and trends


Breeding distribution and range size / trends


Main pressures and threats


SPA coverage and conservation

Biological quality elements
(see Section 1.1)

2011-2020
Strategic Plan describes five strategic goals

Habitat:
– Range, extent, condition

Species:
– Range, population size and condition

Population
dynamics and viability

Species:
– Range, habitat, distribution and abundance

Not
defined

Assessment indicators measured / monitored

See
commission decision (2010/477/EU)

Common
indicators under discussion at OSPAR level

No
EU-level indicators

UK:
Common Standards Monitoring for protected sites and FCS indicators.

Not
defined

Indicators
determined via intercalibration across MSs
(see WFD-TAG UK classification tools
[WFD-TAG, 2014])

Indicators
under development likely to include:


Breeding bird populations


Priority species and habitats


Protected areas


Sustainable fisheries


Invasive species


Marine ecosystem integrity

Seal
population trends

Harbour
porpoise by-catch

Fisheries
spawning stock biomass and size

Eutrophication

Imposex

Oiled
sea birds

Hazardous
substance levels in seabird eggs

Plastic
particle levels in fulmar stomachs

Not
defined

Not
defined

Indicator targets / thresholds for acceptable
vs unacceptable effects or status

Not defined

Not defined

Not defined

Class thresholds determined via inter-calibration
across MSs within Geographic Inter-calibration Groups

Not defined

Each indicator (Ecological Quality Objective –
EcoQO) has an associated target value for the North Sea Region only

Not defined

Not defined

Geographic scope

Member
State waters from baseline (excluding transitional waters) to Exclusive
Economic Zone (EEZ), including extended continental shelf and WFD coastal
waters

Designated
habitats within MSs. Marine waters out to EEZs, including continental shelf,
and WFD transitional and coastal waters

EU
MS territory

All
EU MS territory water bodies in river basins, including transitional and
coastal waters one nautical mile from baseline

Within
national jurisdiction limits of 193 Contracting Parties globally

North-East
Atlantic maritime area

Any
State that exercises jurisdiction over any part of the range of that
migratory species

Territorial
seas of coastal states out to 12 nautical miles from the baseline of 157
Contracting Parties

Baseline conditions

OSPAR Guidance

Conditions
in line with prevailing physiographic, geographic and climatic conditions

EC Guidance

Favourable
reference values

Range
and area viability (habitats), or range and population size (species)

Can
use a 1994 baseline (UK) or historical data, where appropriate

Agreed
baseline of 1979 for all MSs

Directive text

Conditions
that are not/minimally anthropogenically impacted (i.e. conditions
specified for each water body / habitat type)

Varied
baselines used and must be articulated for several targets within the
2011-2020 Strategic Plan for Biodiversity

EcoQOs
use varied baselines

Threatened
or declining habitats / species use historic, recent or current baseline

QSR
assessment uses former natural conditions as baseline

Not
defined within CMS. UK has used HD baselines for species also listed on that
Directive

Not
defined