(01/12/06) REACH: 20 jaar wachten zonder verplichting veilige alternatieven voor giftige chemicaliën ...

• 2006-12-01

Het compromis dat het Parlement bereikte met de Raad over REACH zal de mogelijke gunstige effecten van de wetgeving erg beperken wanneer het erom gaat mens en milieu te beschermen van giftige stoffen. De milieucommissie van het EP had nochtans gevraagd om het substitutieprincipe verplicht toe te passen. Dit had betekend dat erg giftige stoffen moesten vervangen worden door minder schadelijke alternatieven. De lobby (vanuit bepaalde landen) als het Parlement (vanuit de Europese Volkspartij) heeft het evenwel gehaald.

Als dit compromis het inderdaad haalt, is dit zeer betreurenswaardig. Het dossier sleept nu al aan sinds 1998 en sommige bepalingen in REACH zullen pas 11 jaar na de inwerkingtreding van de wetgeving van kracht worden. In de wetenschap dat er alternatieven bestaan, is het ronduit schandalig dat EU-burgers na 20 jaar wachten een wetgeving krijgen die hen nog niet volledig beschermt tegen giftige chemicaliën.

REACH (EU chemicals rules)
Parliament sells out to intense lobby from German chemicals industry

Following the agreement of a second reading compromise on the REACH regulation between the European Parliament and the Council (1) yesterday evening, Green MEP and REACH shadow rapporteur, Carl Schlyter said: "The EP has finally sold out to the intense lobbying of the German chemical industry and agreed a compromise with the Council, which will seriously limit the potential benefits of REACH in terms of protecting EU citizens and the environment from toxic chemicals. The second reading vote in the EP's Environment Committee clearly gave the rapporteur a mandate to push for the mandatory substitution of all chemical substances of high concern when safer alternatives exist. However, back door politics on the part of the chemicals industry, both through specific countries in the Council and, particularly, through its parliament proxy the EPP, has finally triumphed. Under the compromise reached by the Council and Parliament yesterday evening, many substances of high concern will continue to be allowed on the market even where viable alternatives exist."

UK Green MEP and Environment Committee member Caroline Lucas added: "If this compromise is to be the final chapter for REACH, it represents a sad day for environmental policy in the EU. The review of the EU's chemicals legislation has been in the pipeline since 1998 and some of the provisions of REACH will not come into play until 11 years after the entry into force of the regulation. It is a scandal that EU citizens will have waited 20 years for rules that will continue to allow hazardous chemicals to be used in everyday products, even when safer alternatives exist."

Editors note:
(1) While Council, Commission and the PSE rapporteur Sacconi accepted the provisional agreement, the PPE has yet to commit to the agreement. All they committed to was that they will not make any further requests - but that it will now simply be a yes or no for them.

REACH - what did the Environment Committe vote for -
what is Parliament likely to get?

Comparison to the Council Common Position

Positive = ++

Negative = --

What will we get?

++ Improvements

Animal welfare improvements - significant
Substitution of substances of very high concern - small
Public info about substances of very high concern in articles - mimimal
Chemical Safety report for low-volume substances - minimal
Agency - minimal (purely institutional)
Comitology - minimal (procedural alignment)

-- Deteriorations

More industry confidentiality on identity of substances* - significant
Possibility for appeals against rejection of confidentiality * - significant
Delay of first phase of registration* - small
Longer data protection (against SMEs)* - small
R&D exemptions* - minimal
Uncertainty about scope* - minimal
Lower data requirements - minimal

* rejected in ENVI! (not officially on the table of the negotiations)

What will we NOT get?

-- Improvements (adopted in ENVI)
General substitution when safer alternatives are available - highly significant
Less restrictive definition of substances of equivalent concern - significant
Public information about hazardous substances in articles - significant
Transparency about members of Agency bodies/their interests - significant
More low-volume substances to give base set data - significant
Duty of Care - significant
Equal treatment import articles vs. EU-manufactured articles - significant
Review to accomodate specific problem of nanoparticles - significant
Proportionate cost-sharing between big and small producers - significant
Exposure assessment not linked to specific hazards - significant
Member States to be allowed to go further - significant
Inclusion of polymers within 6 years at the latest - small
Specific provisions for vulnerable populations - small

Annex

Part I: Amendments that were not adopted in ENVI

AGREEMENT: DETERIORATIONS INCLUDED - "compensation" for the EPP-ED

-- Simplification of use and exposure categories

-- First phase of registration delayed by six months

-- Extention of data property rights from 10 to 12 years (at the expense of SMEs)

-- Cheaper and less reliable alternative test for cytogenicity

-- Extention of the scope of substances exempted from registration in research and development

-- More possibilities for confidentiality (trade name, IUPAC nomenclature)

-- Possibilities for appeals or remedies for the rejection of confidentiality requests

Part II: Fate of amendments adopted in ENVI

(number in brackets indicates number of amendment)

(++)Authorisation

ENVI: Application for authorisation always requires substitution plan (103, 110)

(++) AGREEMENT: PARTLY INCLUDED —

- application information about R&D activities for alternatives, if appropriate (!)

- requirement of a substitution plan at initial stage continues to be a smokescreen, as only triggered by evaluation of alternatives by the applicant (Art. 61(4)(e) and (ea))

- substitution plan only mandatory at review stage when safer alternatives are available (Art. 60(3))

ENVI: Substitution: authorisation only if no safer alternative, if risks adequately controlled and if

socio-economic benefits outweigh the risks (73, 99-105, 110- 112)

(++) AGREEMENT: SMALL IMPROVEMENT -

- wording of aim changed from “eventually replaced” to “progressively replaced”

- clarification that PBT and vPvB substances that come under authorisation via 56(f) are excluded from the adequate control route (a mere repair of the defect PBT /vPvB criteria)

- review in six years about possible exclusion of endocrine disruptors from adequate control route

- availability of alternatives only relevant at review stage

LAGREEMENT: DETERIORATION -

- risk of requiring full risk assessment for alternatives

- feasibility of alternatives not considered in general, but specifically for the applicant

ENVI: Authorisation always limited to 5 year (83, 103)

(++) AGREEMENT: SMALL IMPROVEMENT - information from third parties about alternatives to be considered for the duration of the time-limited review

ENVI: No mandate to establish thresholds for substances that are carcinogenic/mutagenic (20)

-- AGREEMENT: NOT INCLUDED - only cosmetic editorial change

ENVI: Less restrictive definition of substances of "equivalent concern" (78)

ENVI: Mandatory review if the circumstances have changed/ new info on possible substitutes (106)

ENVI: Mandatory review if enviro quality standards under IPPC (108) or for water are not met (109)

ENVI: Restrictions in case of urgency (91)

ENVI: Candidate list without prejudice to existing restrictions (77)

ENVI: CMR substances and those newly classified as CMR onto candidate list within 3 months (97)

-- AGREEMENT: NOT INCLUDED

(++) Information to the public

ENVI: Consumers entitled to receive information about all substances in articles (64)

(++) AGREEMENT: SMALL IMPROVEMENT: consumers allowed to get information about substances of very high concern on request, other dangerous substances to be addressed via a review after 12(!) years

ENVI: Substances under authorisation always to be labeled (as such/in preparations/in articles) (114)

ENVI: public interest to override confidentiality claims by industry (123)

-- AGREEMENT: BOTH NOT INCLUDED

(++) Registration

ENVI: Chemical Safety report for all substances, not just for substances above 10 tonnes (46)

(++) AGREEMENT: Minimal improvement - review in 7 years to see whether there is a need to extend the requirement to low-volume substances that are carcinogenic, mutagenic or toxic to reproduction

ENVI: PBT and vPvB assessment to include expert judgement (171)

(++) AGREEMENT: PARTLY INCLUDED - review of criteria in 18 months (poss. repair of a major flaw)

ENVI: Deletion of 1 tonne threshold for downstream uses in chemical safety report (65)

ENVI: Exposure assessment not linked to specific hazards (164)

ENVI: More substances 1-10 tonnes to give full base set data (166)

ENVI: Basic use/exposure info at pre-registration and public register of pre-registration info (53, 57)

E NVI: Earlier registration of substances < 100 tonne that are toxic to aquatic organisms (50)

ENVI: Polymers to be included in REACH at the latest within 6 years (159)

-- AGREEMENT: ALL NOT INCLUDED

-- Duty of Care

ENVI: General Duty of Care as a legal requirement for all substances (28)

-- AGREEMENT: NOT INCLUDED - a recital that adds nothing, but merely explains REACH

-- Animal Tests

ENVI: promotion of non-animal testing included in overall objective (26)

++ AGREEMENT: INCLUDED

ENVI: automatic replacement of animal tests as soon as alternatives are available (45)

++ AGREEMENT: LARGELY INCLUDED

ENVI: new committee on alternative tests for integrated strategy at the agency (122)

(++) AGREEMENT: SMALL IMPROVEMENT - Commission report every three years on the implementation and use of non-animal tests, including on funding for this

ENVI: priority to in vitro tests (42) and toxicogenomics as a new alternative method (43)

ENVI: reconfirmation of testing and marketing ban in cosmetics directive (32)

ENVI: stakeholder commenting period (66, 67, 72)

ENVI: no loopholes for data sharing of vertebrate animal tests via early registration (41+59)

++ AGREEMENT: ALL INCLUDED

ENVI: reduction strategy on short-term toxicity testing (168)

ENVI: information on animal tests to be sent to agency within 18 months (54, 56)

-- AGREEMENT: BOTH NOT INCLUDED

(++) Agency

ENVI: Agency management board to include two EP reps and four reps of interested parties (129)

-- AGREEMENT: PARTLY INCLUDED - 2 EP reps in the management board

ENVI: Stronger rules on independence, agency members and declarations of interest to be public (142)

-- AGREEMENT: NOT INCLUDED [in other words: agency members and declarations of interest can be confidential)

ENVI: Increased transparency through publication of internal rules and authorisation info (148)

-- AGREEMENT: NOT INCLUDED

-- Substances in articles

ENVI: homogenous materials as reference for 0,1% for registration/notification of substances of very high concern in consumer articles (33, 38)

ENVI: earlier restriction of substances of very high concern in import articles (119)

-- AGREEMENT: NOT INCLUDED

-- Nanoparticles

ENVI: review of tonnage threshold and adequate info requirements within 18 months (161), full base set data for nanoparticles 1-10 tonnes (165), to fall under authorisation and to be given priority thereunder (79, 87)

-- AGREEMENT: NOT INCLUDED

-- Vulnerable populations

ENVI: their vulnerability to be considered for restrictions (117) and in chemical safety reports (163)

-- AGREEMENT: NOT INCLUDED

(++) SMEs

ENVI: notification of non-registration to DU, extra six months for registration by DU (51, 55)

(--) AGREEMENT: SMALL IMPROVEMENT — addressed only in a recital, only vague help of little value

ENVI: sharing of data and registration costs by production volume (52, 56, 59)

ENVI: Participation of formulators in SIEFs (58)

-- AGREEMENT: NOT INCLUDED

(++) Comitology (procedural alignment)

ENVI: Parliament to have veto powers in 15 out of 23 comitology decisions

++ AGREEMENT: INCLUDED - Parliament to have veto powers in 10 out of 23 comitology decisions, authorisations under regulatory procedure instead of advisory procedure

(++) Other

ENVI: maintaining of national implementation measures of restrictions (116)

++ AGREEMENT: Repeal of 76/769 delayed by two years, plus Commission guidance (Art. 134, 136, 138)

ENVI: Member States to be allowed to maintain/introduce more stringent requirements (154)

ENVI: Parliament to have co-decision for new restrictions (120)

-- AGREEMENT: NOT INCLUDED