EU Directives Flashcards
Legislation - EU Directives
- RoHS Directive
- REACH Directive
- Ecodesign Directive
- Energy Labelling Directive
RoHS I
- Restriction of Hazardous Substances in electrical and electronic equipment
- from 2003, update 2011 by improving regulatory conditions and legal clarity
- big driver for ecodesign
- background: Problems of huge amounts of toxic electronic waste
- directive restircts the use of certain hazardous materials in the manufacture of varouis types of electronics and electrical equipement
- it is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2006 which sets collection, recycling and recovery targets for eletrical goals
- restricted substances: Lead, mercury, admium, PBB, PBDE…
Restrictions:
- general: 0.1 % (1000 ppm)
- Cadmium: 0.01% (100 ppm)
- -> the restrictions are on each homogeneous material in the products –> limits do not apply to the weight of a finished product or even to a component but to any single substance that could (theoretically) be separated mechanically
RoHS II
• Background: Problems of huge amounts of toxic electronic waste
• Directive restricts the use of certain hazardous materials in the manufacture
of various types of electronic and electrical equipment
• It is closely linked with the Waste Electrical and Electronic Equipment
Directive (WEEE) 2002/96/EC which sets collection, recycling and recovery
targets for electrical goods
RoHS - restricted substances
Restricted substances – Lead ( Pb – Mercury ( Hg – Cadmium ( Cd – Hexavalent chromium (Cr 6+ – Polybrominated biphenyls ( – Polybrominated diphenyl ether ( – Bis(2 ethylhexyl) phthalate ( – Butyl benzyl phthalate ( – Dibutyl phthalate ( – Diisobutyl phthalate (
RoHS III
• Restriction
– General: 0.1% (1000 ppm)
– Cadmium: 0.01% (100 ppm)
• The restrictions are on each homogeneous material in the product!
–> Limits do not apply to the weight of a finished product
–> or even to a component
–> but to any single substance that could (theoretically)
be separated mechanically
RoHS IV
• More than 80 restriction exemptions , e.g.:
– Copper alloy containing up to 4% lead by weight is permitted
– Lead in high melting temperature type solders (i.e. lead based solder alloys
containing 85% by weight or more lead)
– Cadmium in solar panels Cadmium telluride ( CdTe ) thin film PV modules in
photovoltaic panels
– Limited amounts of mercury in fluorescent and other light bulbs where it is
essential to their functioning
REACH
R egistration
E valuation
A uthorization and Restriction of
Ch emicals
Why REACH?
• Past EU legislative framework for chemical substances was a patchwork of
many different Directives and Regulations which has developed historically
• Different rules for “existing” and “new” chemicals (before / after 1981)
–> Insufficient information about the
effects of the majority of existing
chemicals (> 100,000) on human
health and the environment
–> Slow identification, assessment
and management of risks
covering the hazards of a
substance and exposure of
humans and environment to it
• Past system hampered research and innovation, causing the EU chemicals
industry to lag behind its counterparts in the US and Japan in this regard
• Ineffective allocation of responsibilities between authorities and companies
• On the other hand, new chemicals had to be notified and tested starting
from volumes as low as 10 kg per year barrier to innovation
Aims and Objectives of REACH
• Aims: Improve protection of human health and the environment from risks of
chemicals while enhancing competitiveness of EU chemicals industry
• Seven objectives that needed to be balanced within the overall framework of
sustainable development
1. Protection of human health and the environment
2. Maintenance and enhancement of the competitiveness of the EU chemical industry
3. Prevention of fragmentation of the internal market
4. Increased transparency
5. Integration with international efforts
6. Promotion of non animal testing
7. Conformity with EU international obligations under the WTO.
Elements
of REACH
- Scope of substances covered by REACH
- Registration of chemicals to obtain information used to manage them safely
- Data sharing to reduce animal testing
- Information exchange along the supply chain
- Downstream users
- Evaluation by the Agency
- Authorization of substances of very high concern
- Restrictions to limit or ban dangerous substances
- European Chemicals Agency (ECHA) will manage REACH
- Classification and labelling inventory of dangerous substances
- Access to information
REACH - Registration
Substances on their own or in preparation
• Substance: A chemical element and its compounds
• Manufacturers and importers of substances are obliged to submit a registration to the Agency
• Registration contains information to assess the risks arising from the uses and to ensure that the risks are properly managed
– Technical dossier, for substances in quantities of 1 tone or more, and
– Chemical safety report, for substances in quantities of 10 tones or more
• Based on risk assessment substances can be categorized as “Substances of
Very High Concern” (SVHC) and registered in a candidate list
• Based on risk assessment (Annex XV) substances can be categorized as
“Substances of Very High Concern” (SVHC), if they
– carcinogenic, mutagenic or toxic to reproduction (CMR) category 1 and 2,
– persistent, bioaccumulative and toxic (
– very persistent and very bioaccumulative vPvB ), and
– identified from scientific evidence as causing probable serious effects to humans
or the environment equivalent to those above on a case by case basis, such as
endocrine disrupters
REACH - Evaluation
1) Dossier evaluation: Quality check of the registration dossiers
• Compliance check:
– The Agency may check the compliance of registration dossiers with the
requirements laid down for registration in the Regulation
– At least 5% of dossiers should be checked
• Checking of testing proposals:
– Aim: prevent unnecessary animal testing, i.e. the repetition of existing tests, and
poor quality tests
2) Substance evaluation:
• The Agency in co ordination with the Competent Authorities of Member
States may clarify suspicions of risks to human health or the environment by
requesting further information from industry
• To promote a consistent approach, the Agency will, in co operation with the
Member States, develop guidance on the prioritization of substances for
further evaluation
REACH - Authorization
- Agency:
– Selection of SVHC from candidate list for which authorization is requested
(some can be excluded because sufficient controls established by legislation
already in place) - Industry:
– Has to apply for authorization if such a substance shall be used or made available
– Analysis of possible substitutions
– Authorization will be granted if the applicant can demonstrate that the risk from
the use of the substance is adequately controlled
– It may also be granted if the socioeconomic benefits outweigh the risks and there
are no suitable alternative substances or processes
REACH Restriction
• If the commission or a member state see an unacceptable risk for human
health or the environment, they can propose the restriction of a SVHC
• Procedure outlined in Annex XV:
– Risk assessment
– Also analyzes socio economic consequences of a restriction
– Analysis of substitutes
– Cost benefit analysis
– Public consultation
• Options of restriction:
– Total prohibition of production, use and marketing
– Restriction under conditions: concentrations or certain uses
Consequences of RoHS and REACH
• Manufacturers need to make sure to obey to legislation:
– Information on restricted substances (RoHS) and SVHC (REACH) in their products
– Meeting the restriction requirements of RoHS and REACH
• Tools presented in the next lectures:
– BOMcheck
– Global Automotive Declarable Substance List
– International Material Data System (IMDS)
