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New EC chemicals law to be in place by 2005
New EC chemicals law to be in place by 2005 New laws governing chemicals in the European Union are taking shape in Brussels and are expected to take effect by 2005 at the latest. The legislators have decided that metals should be classed as chemicals, and that will have a significant impact on the PM business. Kennametal'sKlausGoertingandtheEPMA'sTechnicaIDirector, PeterBrewin, set out some proposed responses from the European Hard Materials industry at the Euro PM2002 Conference in Lausanne last month, which centred on hard materials and diamond tooling... EU New Chelnicals Policy ( N C P ) will place responsibility on manutacturers, importers and traders t~} generate knowledge about chemic'als with the objective of ensuring that chemicals that are safe fi~r the intended use are produced or inarketed. The legislation is currently [~eing drafted, t~ut it is expected to Become l~lw in 2004/2005 and will be introduced :s a Regulation - enfi~rced directly from Brussels with n~
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IlE
I'I~OI'O.qE[~
Peter Brewin
Klaus Goerting
allowance for freedom of local interpretation. Setting o u t the recent history of the NCP, Goerting and Brewm said that it came about as 'a result of
growing feeling in political quarters that chemicals were being placed on the market without proper control, often with little test data to identify a n y hazards in their use. These legislative shortfalls were seen against a background in which ever-increasing tonnages of chemicals were being produced and new chemicals being developed. Well-publicised fuilures were seen with asbestt~s and DDT. Some chemicals related diseases are known to have i n c r e a s e and some chemicals a r e known to
The hard materials industry has much improved handling techniques during manufacture and it's general environmental record.
12
Nove m b e r
2002
0026-0657/02/$ - see front matter © 2002 Elsevier Science Ltd. All rights reserved,
Figure z - Testing ~ u i r e m e n t s (according to 67/548/EC Article 7)
1 - 10 tonnes per year General data plus in-vitro tests 10 - 100 tonna$ per year Basic tests: Acute toxicity, rnutagenic effects; acute fish toxicity; bacterial inhibition; sub-chronic toxicity; teratogenic effects; algae growth; bio-decom. position. 100-:LO00 tonnes per year Add Level 1 tests: Reproductive toxicity; teratogenic effects; toxico-kinetic base information; sub-chronic/chronic toxicity; mutagenic effects. Over 1 0 0 0 tonnes per year Add Level 2 tests: Chronic toxicity; toxico-kinetic information; fish toxicity; toxicity with other organisms: carcinogenic effects; bioaccumulation, biodecomposition; toxicity tests with birds.
play a causative role in allergies. They noted that the proposed legislation would affect many countries outside the Ell, some of which have very advanced environmental standards of their own. "In February 2002 the US Environmental Protection Agency held a workshop entitled 'Developm e n t of a Metals Assessment Framework' the general consensus of which was that the 'Persistent, Bioaccumulative and Toxic (PBT)' methodology of characterising hazardous waste originally developed for organic chemicals is inappropriate for metals. "Because of bioavailability considerations it was proposed that for metals PBT should be replaced by methodology taking into account bioavailability, speciation and transformation. The focus of the workshop was the validity of applying to metals two key organic chemical hazard definitions. A n organic chemical is regarded as persistent in the environment when its half-life in soil, water or sediment is greater than two months. It is regarded as toxic if it is hazardous at concentrations as low as lmg per litre. "It is clear," say the authors, "that the definition of persistence needs to be modified in the case of metals to take account of bioavailability. The toxicity definition must take into account both transformation and
www.metal-powder.net
solubility as well as bioavailability, as hazardous metals pose negligible risk if they are not bioavailable.' Unlike organic chemicals, the metals industry does not develop new substances, relying instead on its expertise in getting the best properties out of existing substances by processing and alloying. In general it deals with materials the effects of which are well understood. The European Hard Materials industry has done much to promote human health and the preservation of the environment in recent years. Improvements in hardmetal toughness have greatly extended the life of tools and the range of applications into many areas previously covered by shorter-life cutting steels.
Environmental impact reduced
Further i m p r o v e m e n t s in substrates, coatings and tool geometry have made it practicable for many hardmetal tools to operate without cutting lubricants, greatly reducing the environmental impact of swarf disposal. And at the end of its useful life, the expensive elements of larger carbide components are reclaimed, typically using zinc reclamation. The occupational health aspects of hard materials manufacture are also well developed, and much of the processing and part handling is fully automated.
However, the new regulation is likely to be all-embracing. For while under existing legislation the burden of proof rests with the authorities, a key element of the N C P is that this burden now shifts to manufacturers and importers, who will be responsible for registration. The critical point here is that without satisfactory registration, both production and trade become illegal. Registration of substances will be carried out under the REACH system. This is the acronym for the Registration, Evaluation, and Authorisation of Chemicals, under which all chemicals manufactured pr imported into the EU at more than 1 ton per annum (tpa) must be registered with the authorities. Thos produced or imported in tonnages over 100 tpa must be evaluated by the authorities before they are allowed into the EU. Chemicals of high concern that are carcinogenic, mutagenic or toxic to reproduction will only be authorised for use if their application is demonstrated, and authorisation will be use-specific. The procedures involved in registration are onerous and the testing requirements extensive. These together, along with the likelihood of additional "authorisation charges" 150 000 to 450 000 are being discussed per use of each substance are being discussed - are likely to see many substances phased out. Deadlines are set for implementation of the policy based on annual tonnages. The requirements for the NCP registration portfolio are likely to be: • Identity and properties of the substance, including test data on hazards to human health and environment; • Intended uses including human and environmental exposure data; • Planned production levels; • Proposals for classification and labelling; • A safety data sheet; • Preliminary risk assessment covering the intended uses; and • Proposed risk management measures. In terms of authorisation, Goerting and Brewin say that the majority of
::~iid{ November 2002
13
Mine (Ore)
Registration?
Refiner
Registration?
Powder producer (W, WC, Co etc = substances) Premixes sold to third parties = Non-site limited intermediates
Registration of substances Data on intermediates
Parts producer (Articles, primary products)
Use
Finisher (Primary products into articles)
Use (controlled occupational)
Industrial use (Cutting, tooling, wear parts)
Consumer use (Mostly cutting)
(controlled occupational)
Use (Mostly controlled;
controlled recycling) Use (Mostly uncontrolted; limited recycling)
hard material uses "will almost certainl,/not" be subject to it. An exception, they add, could be the toxicity and possible carcinogenicity of hardmetal blends. Metals will probably nL~t be regarded as persistent, bioaccumulative and toxic on the basis of bioavailability testing. "On the basis of current classifications, therefi~re, we do not as a direct result of the NCP expect significant research activity in developing lowhazard substitutes fi)r hazardous substLtnces,"
substantial part of it, the authors conclude that metals should be treated on their own merits in the legislation and its application. To assist that, Goerting and Brewin say that producers will need to fill "significant gaps" in available data and that downstream users can
Component
Physical/ Chemical Data
discharge their responsibilities in the registration process by providing good quality data on use. Trade associations, too, have a big role to play, they say. industryrepresentative bodies can legitimately lobby authorities ~>n behalf of their members, while minimising duplication of effort by encouraging efficient liaison between their members and other trade associations.
Light needed as weU as heat
There needs, however, to be light as well as heat, so the co-ordination of industry personnel in expert working groups and in generation of initial data, particularly in the health and environmental fields is very important. Additionally, co-ordination of data gathering on both occupational and consumer use and exposure helps to add colour to the picture f~r the legislators and civil serwmts who will eventually word the new regulations.
Human Toxicity
Eco Toxicity
wc w
Whole chain affected
It is clear, they conclude, that the NCP will affect the entire hard materials production supply chain and it is expected that the larger powder manufacturers and importers will register and, jointly with down stream users, provide the full portfolio for risk management and risk assessment. New toxicity data is likely to be required on inany substances involved in the manufacture of hard materials, especially to demonstrate envir{~nmental effects. }{ut with the possible exception of carbide- cobalt blends the hard materials industry does not expect to be subject to use authorisation. But recognising a possible threat t~ the competitiveness of the European industry and the many small businesses that make up a
1/4
November
2002
TiC T~C Sa vc
Cr3C2 Mo2C Mo
~
I
TiN TICN Co Ni Fe
Key Almost sufficient data Some data available
Limited, or no data available
www.metal-powder.net
T
IlE
I'I~OI'O.qE[~
Peter Brewin
Klaus Goerting
allowance for freedom of local interpretation. Setting o u t the recent history of the NCP, Goerting and Brewm said that it came about as 'a result of
growing feeling in political quarters that chemicals were being placed on the market without proper control, often with little test data to identify a n y hazards in their use. These legislative shortfalls were seen against a background in which ever-increasing tonnages of chemicals were being produced and new chemicals being developed. Well-publicised fuilures were seen with asbestt~s and DDT. Some chemicals related diseases are known to have i n c r e a s e and some chemicals a r e known to
The hard materials industry has much improved handling techniques during manufacture and it's general environmental record.
12
Nove m b e r
2002
0026-0657/02/$ - see front matter © 2002 Elsevier Science Ltd. All rights reserved,
Figure z - Testing ~ u i r e m e n t s (according to 67/548/EC Article 7)
1 - 10 tonnes per year General data plus in-vitro tests 10 - 100 tonna$ per year Basic tests: Acute toxicity, rnutagenic effects; acute fish toxicity; bacterial inhibition; sub-chronic toxicity; teratogenic effects; algae growth; bio-decom. position. 100-:LO00 tonnes per year Add Level 1 tests: Reproductive toxicity; teratogenic effects; toxico-kinetic base information; sub-chronic/chronic toxicity; mutagenic effects. Over 1 0 0 0 tonnes per year Add Level 2 tests: Chronic toxicity; toxico-kinetic information; fish toxicity; toxicity with other organisms: carcinogenic effects; bioaccumulation, biodecomposition; toxicity tests with birds.
play a causative role in allergies. They noted that the proposed legislation would affect many countries outside the Ell, some of which have very advanced environmental standards of their own. "In February 2002 the US Environmental Protection Agency held a workshop entitled 'Developm e n t of a Metals Assessment Framework' the general consensus of which was that the 'Persistent, Bioaccumulative and Toxic (PBT)' methodology of characterising hazardous waste originally developed for organic chemicals is inappropriate for metals. "Because of bioavailability considerations it was proposed that for metals PBT should be replaced by methodology taking into account bioavailability, speciation and transformation. The focus of the workshop was the validity of applying to metals two key organic chemical hazard definitions. A n organic chemical is regarded as persistent in the environment when its half-life in soil, water or sediment is greater than two months. It is regarded as toxic if it is hazardous at concentrations as low as lmg per litre. "It is clear," say the authors, "that the definition of persistence needs to be modified in the case of metals to take account of bioavailability. The toxicity definition must take into account both transformation and
www.metal-powder.net
solubility as well as bioavailability, as hazardous metals pose negligible risk if they are not bioavailable.' Unlike organic chemicals, the metals industry does not develop new substances, relying instead on its expertise in getting the best properties out of existing substances by processing and alloying. In general it deals with materials the effects of which are well understood. The European Hard Materials industry has done much to promote human health and the preservation of the environment in recent years. Improvements in hardmetal toughness have greatly extended the life of tools and the range of applications into many areas previously covered by shorter-life cutting steels.
Environmental impact reduced
Further i m p r o v e m e n t s in substrates, coatings and tool geometry have made it practicable for many hardmetal tools to operate without cutting lubricants, greatly reducing the environmental impact of swarf disposal. And at the end of its useful life, the expensive elements of larger carbide components are reclaimed, typically using zinc reclamation. The occupational health aspects of hard materials manufacture are also well developed, and much of the processing and part handling is fully automated.
However, the new regulation is likely to be all-embracing. For while under existing legislation the burden of proof rests with the authorities, a key element of the N C P is that this burden now shifts to manufacturers and importers, who will be responsible for registration. The critical point here is that without satisfactory registration, both production and trade become illegal. Registration of substances will be carried out under the REACH system. This is the acronym for the Registration, Evaluation, and Authorisation of Chemicals, under which all chemicals manufactured pr imported into the EU at more than 1 ton per annum (tpa) must be registered with the authorities. Thos produced or imported in tonnages over 100 tpa must be evaluated by the authorities before they are allowed into the EU. Chemicals of high concern that are carcinogenic, mutagenic or toxic to reproduction will only be authorised for use if their application is demonstrated, and authorisation will be use-specific. The procedures involved in registration are onerous and the testing requirements extensive. These together, along with the likelihood of additional "authorisation charges" 150 000 to 450 000 are being discussed per use of each substance are being discussed - are likely to see many substances phased out. Deadlines are set for implementation of the policy based on annual tonnages. The requirements for the NCP registration portfolio are likely to be: • Identity and properties of the substance, including test data on hazards to human health and environment; • Intended uses including human and environmental exposure data; • Planned production levels; • Proposals for classification and labelling; • A safety data sheet; • Preliminary risk assessment covering the intended uses; and • Proposed risk management measures. In terms of authorisation, Goerting and Brewin say that the majority of
::~iid{ November 2002
13
Mine (Ore)
Registration?
Refiner
Registration?
Powder producer (W, WC, Co etc = substances) Premixes sold to third parties = Non-site limited intermediates
Registration of substances Data on intermediates
Parts producer (Articles, primary products)
Use
Finisher (Primary products into articles)
Use (controlled occupational)
Industrial use (Cutting, tooling, wear parts)
Consumer use (Mostly cutting)
(controlled occupational)
Use (Mostly controlled;
controlled recycling) Use (Mostly uncontrolted; limited recycling)
hard material uses "will almost certainl,/not" be subject to it. An exception, they add, could be the toxicity and possible carcinogenicity of hardmetal blends. Metals will probably nL~t be regarded as persistent, bioaccumulative and toxic on the basis of bioavailability testing. "On the basis of current classifications, therefi~re, we do not as a direct result of the NCP expect significant research activity in developing lowhazard substitutes fi)r hazardous substLtnces,"
substantial part of it, the authors conclude that metals should be treated on their own merits in the legislation and its application. To assist that, Goerting and Brewin say that producers will need to fill "significant gaps" in available data and that downstream users can
Component
Physical/ Chemical Data
discharge their responsibilities in the registration process by providing good quality data on use. Trade associations, too, have a big role to play, they say. industryrepresentative bodies can legitimately lobby authorities ~>n behalf of their members, while minimising duplication of effort by encouraging efficient liaison between their members and other trade associations.
Light needed as weU as heat
There needs, however, to be light as well as heat, so the co-ordination of industry personnel in expert working groups and in generation of initial data, particularly in the health and environmental fields is very important. Additionally, co-ordination of data gathering on both occupational and consumer use and exposure helps to add colour to the picture f~r the legislators and civil serwmts who will eventually word the new regulations.
Human Toxicity
Eco Toxicity
wc w
Whole chain affected
It is clear, they conclude, that the NCP will affect the entire hard materials production supply chain and it is expected that the larger powder manufacturers and importers will register and, jointly with down stream users, provide the full portfolio for risk management and risk assessment. New toxicity data is likely to be required on inany substances involved in the manufacture of hard materials, especially to demonstrate envir{~nmental effects. }{ut with the possible exception of carbide- cobalt blends the hard materials industry does not expect to be subject to use authorisation. But recognising a possible threat t~ the competitiveness of the European industry and the many small businesses that make up a
1/4
November
2002
TiC T~C Sa vc
Cr3C2 Mo2C Mo
~
I
TiN TICN Co Ni Fe
Key Almost sufficient data Some data available
Limited, or no data available
www.metal-powder.net