Cristina de Avila
DG Environment, Sustainable Chemicals Unit
For:
Ministry for the Environment
Government of Japan
17 March 2022
Latest progress in EU new chemicals strategy

2030 vision – towards a toxic-freeenvironment• Chemicals are produced/used in a way thatmaximises their benefits to society while
avoiding harm to planet & people• Production and use of safe and sustainablechemicals becomes the EU market norm and aglobal standardTOXIC-FREE ENVIRONMENT: 5 building
blocksInnovation,competitiveness,recovery

Simplification &coherence

Strengthen
legislation forbetter protection

Knowledge andscience

Global

1. Boosting innovation
Promote the transition to safe and sustainable chemicals,materials and products• New chemicals and materials inherently safe andsustainable• Green transition of chemical sector• Promoting EU open strategic autonomy forcritical chemicals – technologies for climate
neutrality

Safe and sustainable-by-design
An approach to the design,development and use ofsubstances, materials and/orproducts that focuses on:• providing a function (orservice)• while preventing harmful
impacts to human health andenvironment throughout
their lifecycle (from raw
material to final disposal)

Innovation - main actions• Develop EU safe and sustainable-by-design criteria• EU-wide support network• Provide EU funding for the green and digital transition of the

production/use of chemicals (Horizon Europe, recovery
instruments, cohesion funds, Life)• Strengthen EU’s open strategic autonomy for critical chemicals• Address skills and competence gaps
• Establish key performance indicators measuring industrialtransition• Industrial emissions legislation to promote use of saferchemicals

Sustainable Products Regulation• Revises Ecodesign Directive• Make products on EU market more sustainable• Addresses harmful chemicals in electronics & ICT equipment, textiles, furniture, steel, cement• Information requirements and tracking of substances of concern

2. Strengthening legislation•••

Endocrine
disruptors

All chemicals on the market to be used safely andsustainably.
Substitute and minimise as far as possible substancesof concern
Avoid the most harmful chemicals in consumer
products esp. for vulnerable groups
PFAS

New hazard classes

Mixtures

Environmental
impactConcept of ‘essential uses’Essential uses – the concept• The Commission will :• define criteria for essential uses (2021-2022) to ensure that the most harmful

chemicals are only allowed if• their use is necessary for health, safety or is critical for the functioning ofsociety• there are no alternatives that are acceptable from the standpoint ofenvironment and health• Criteria will:• guide the application of essential uses in all relevant EU legislation for bothgeneric and specific risk assessments• take into account the definition of essential uses in the Montreal Protocol on
Substances that Deplete the Ozone Layer

Essential uses – the process• Study and consultation with stakeholders/experts (workshop 3March 2022)• Mapping of relevant legislation (incl. and beyond REACH)• Definition of criteria• Policy options
Feeding into:
 REACH revision (Impact Assessment) and implementation
 Revision/implementation of other legislation (e.g. Toys Directive,Cosmetics Regulation)

Endocrine disruptors• CLP Regulation (Classification, Labelling and Packaging of chemicals): new hazard

class• Definition based on WHO criteria; criteria in pesticides and biocides regulations;applicable to all EU chemicals legislation• REACH registration: more information requirements on critical hazard

properties (carcinogenicity, endocrine disruption etc.) to ensure hazard
identification and risk assessment• REACH (art. 57) include endocrine disruptors in the definition of substancesof very high concern• REACH (art. 68.2) include endocrine disruptors in the generic risk approach(substances to be avoided in consumer products)

PFAS• Persistent chemicals that accumulate in humans, animals and the environment• Toxic particularly for children’s development• Accumulate in bodies exceeding “tolerable weekly intake” of safe limits, due intake from food anddrinking water (EFSA 2020)• Costs to society from PFAS exposure high (52 to 84 billion EUR Nordic Council of Ministers 2019)• Pollutes ecosystems and generates costs for remediation of soil and water.
• Main sources of contamination from production and use: for example from fluoropolymer production

installations• PFAS group includes 4 700 substances• Wide variety of use: consumer products, industrial applications, pesticides and pharmaceuticals• Limited information about which PFAS are used in which applications and at what levels in Europe

REACH and PFAS
• Group restriction• Preparatory work for a group restriction on all uses of PFAS (exceptessential uses): 4 Member States + Norway• https://echa.europa.eu/-/restriction-of-per-and-polyfluoroalkylsubstances-pfas-under-reach• PFAS in fire-fighting foams• More information ECHA hot topics page
• https://echa.europa.eu/hot-topics/perfluoroalkyl-chemicals-pfas

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Mixtures – combination effects ofchemicals• Unintentional exposure to a combination of substances can lead to adverse effects

on people and the environment.
• REACH: single substance safety information – co-exposure with other substances

not taken into account• A mixtures assessment factor (MAF) is a pragmatic approach to manage theunknown• To ensure a level of protection against unintended mixture effects like for a single substancechemical safety assessment.

Environmental impact
Focus on addressing chemicals that pose risks for the environment• New hazard classes in CLP (addressing environmental toxicity, persistency,

mobility and bio-accumulation)• Ensure authorities have sufficient information for environmental risk assessments:

stricter information requirements across legislation• Address the impact of production and use of pharmaceuticals• Support research and development for decontamination technologies• Reinforce regulation of chemical contaminants in foodNew Hazard classes••

Endocrine Disruptors
Persistent Bioaccumulative and Toxic (PBT) and very
Persistent and very Bioaccumulative (vPvB)••(categorisation system)

Persistent Mobile and Toxic (PMT) and very Persistentand very Mobile (vPvM)•(categorisation system)3. Simplifying and consolidating• Strengthen compliance, enforcement

and market surveillance (‘zerotolerance to non compliance’)• ‘One substance, one assessment’process to make safety assessment
processes• simpler and more transparent• faster as well as more consistentand predictable

One substance one assessment
Initiation

Allocation

Data

Methodologies

Today• Plethora of legislation• European
Commission, Member
States, Industry• At different times• Agency• Expert Group• ScientificCommittee• Consultant• Availability• Formats• Access• Quality• Guidelines• GuidanceTomorrow• Synchronised andcoordinated• Assessments ofgroups of substances• Clear
responsibilities• Making best useof available
resources andexpertise• Goodgovernance andcooperation• Easy to find,access, operate
betweendifferent
systems, secure,high quality• Shared andreused bydefault• Coherent• Harmonised asmuch as possible• Hazard
assessment
centralised
under CLP
Regulation

Organisation of work – one substance one
assessment• Developing coordination mechanism (extension ofACT/PACT and expert working group)• CLP Revision• Horizontal legislative proposal for reallocation oftechnical and scientific work to Agencies• Proposal for ECHA’s founding regulation• Data, tools and platforms• Horizontal legislative proposal on data flows

4. A comprehensive knowledge base
• Establish a EU research & innovation agenda

for chemicals, incl. to promote innovative testingand (Bio)-monitoring• Improve knowledge on chemical properties anduses
 by requiring more information (polymers,environmental footprint, low volumes, for
specific hazard properties)
 by tracking substances on concerns inproducts/materials

5. Setting the example globally• Global strategic objectives and targets

beyond 2020
• Promote the use of the Globally Harmonized

System of Classification and Labelling ofChemicals (GHS) and propose new hazard
classes• Sound management of chemicals ininternational cooperation• Chemicals banned in the EU not for export

High Level Roundtable• Industry• Non-governmental organisations• Universities, researchers• Member States (represented by EU presidency)• International organisations (UN, OECD, WHO)• 32 members• Role: help European Commission implement the chemicals strategy forsustainability; act as ambassador for the strategy.
• Discussion topics: enforcement, research and innovation, global dimension….

Thankyou
Thank you© European Union 2020
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