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
High-level protection goals	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 K_ow >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)
Ecological entities considered	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		- Reduce priority substance pollution
					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 K_ow) - Reproductive health
					Groundwater quantity criteria			Chemical (loads) for releases to: - Air - Water - Land	Long-term maintenance of soil: - Structure - Function
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)
Assessment indicators measured / monitored						- Chemicals in biota (see Article 3)	Chemicals only (polluting substances listed in Annex II)		Indicators likely linked to main threats
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 K_ow 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