Sean Milmo, European Editor11.21.16
European Union officials have been reiterating their intention to be sympathetic to the problems of chemicals suppliers in complying with the EU’s REACH legislation, particularly the need to register low-volume substances by mid-2018.
This more conciliatory approach is coming as a relief to ink producers worried that the failure to register chemicals by some smaller companies by the mid-2018 deadline would leave them without some vital ingredients in their formulations.
The deadline is for the registration by producers or importers of chemicals with annual outputs of one to 100 tons – the last of three tranches with the other two larger volume categories having registration deadlines in 2010 and 2013.
The final group of chemicals covers two-thirds of the approximate total of 30,000 substances covered by REACH, which requires the registration of each chemical to be accompanied by a safety profile. The vast majority of registrants in 2018 will be SMEs, many of whom could find the registration of their products a burden on both their financial and human resources.
Some producers of pigments, additives and niche substances, particularly in countries outside Europe like China, have been warning that they may not register their low-volume products because the registration costs would eliminate their profits.
Chemicals not registered by producers or importers after mid-2018 cannot be sold in the EU market.
“We will make sure that substances critical for downstream sectors will be registered,” Geert Dancet, executive director of the Helsinki-based European Chemicals Agency (ECHA) - which administers REACH - told the annual assembly of the European Chemical Industry Council (Cefic) in Florence in October.
Cefic is Europe’s main trade association for the chemical industry, covering both bulk and speciality chemicals.
ECHA and the European Commission, the EU’s Brussels-based executive to which the agency is accountable, have also been giving other assurances on a number of other issues on REACH that have been worrying downstream sectors, particularly formulators of products like inks, coatings and adhesives.
Within the sector for printing inks and related products, a major anxiety has been the cost of obtaining safety data for inclusion in the REACH registration dossiers.
In addition, the dossiers have to contain information on the downstream use of chemicals. With inks, this information can be complicated, particularly with regard to how downstream workers might be exposed to dangerous substances.
Recently, a new concern for suppliers and users has been an increasing likelihood that chemicals previously regarded as being safe could be treated by the authorities as being dangerous.
There is already an outside possibility that this could happen with titanium dioxide (TiO2) under the EU’s Classification, Labelling and Packaging (CLP) regulation, which is being implemented in parallel with REACH. Products with TiO2 could then have to be labeled as being hazardous.
Another issue, which could have a safety impact in the longer term, is the health, safety and environmental (HSE) status of nano particles in inks, coatings and similar products.
Currently, HSE experts consider that there is insufficient data available to draw up an adequate safety profile of nanomaterials in inks, coatings and similar formulated products.
Risk assessment of mixtures of different substances within compounds and formulations is also regarded as being another challenge because in certain cases not enough is known about whether the chemicals interact in ways that could be hazardous.
With all these uncertainties, the prime purpose of REACH, which is the communication of safety information on each chemical along the supply chain, is being undermined.
“The experience so far is that there is insufficient and unstructured communication up and down the supply chain, (with) information down the supply chain being perceived by downstream users as difficult to use,” Dancet told the Florence meeting.
With so many unresolved problems, REACH will not be receding into the background after the final mid-2018 registration deadline. It will continue to pose dilemmas for chemical and formulation producers, like ink makers, as well as by end users “Overall REACH has worked, but there is still a lot of work to do,” Dancet said. “The journey continues,” he added, listing a number of objectives into the 2020s, including dealing with substances of the most concern because of their degree of hazard and setting up a closer partnership with industry.
The current priority remains sorting out of difficulties with the 2018 registration, particularly for SMEs.
With critical substances threatened by non-registrations, ECHA has agreed to allow users to act as importers so they themselves will arrange and finance the registration of the chemicals.
“The downstream users will themselves be given the opportunity to become the registrants,” explained Janice Robinson, product regulations director for the European Council of Paint, Printing Ink and Artists’ Colours Industry (CEPE), Europe’s main coatings trade association. The European Printing Ink Association (EuPIA) is part of CEPE.
ECHA may even be flexible with the May 31, 2018 registration deadline if downstream users need extra time to organize their own registrations of threatened key substances.
On the matter of SMEs in particular being charged excessive fees to obtain safety data for the registration of their chemicals, the EU has tightened up the rules on data sharing through a Data Sharing Implementing Act, which was approved earlier this year.
Data for registrations can be acquired through membership of groups of producers and importers for each chemical, called substances information exchange forums (SIEFs). The data can also be obtained by non-SIEF members by paying for a “letter of access” to SIEF data.
The objective behind the SIEF system is that each substance goes through a joint registration process – “one substance, one registration” – to avoid submission of dossiers with different sets of data.
Steps have also been taken to ease the task of providing information in dossiers on the use of chemicals by downstream users, which with inks would mainly be printers, but can also include formulators. For downstream users it is crucial that the correct information on their use of a chemical is included in its registration dossier.
ECHA has introduced a system of standardization of the use information on individual chemicals by giving sector associations like CEPE and EuPIA the task for drawing up and providing to suppliers uniform data on uses.
A similar system is being applied to information on what is called “exposure scenarios” describing conditions and possible risks under which end-user staff would be exposed to specific hazardous chemicals.
After the 2018 registration, ECHA has indicated that it will focus much more on improving the quality of data in existing dossiers, which could mean giving more details about uses and exposure scenarios. Registrants could be requested to give more accurate data in their dossiers.
The agency’s strategy would nonetheless be to “concentrate on substances that matter,” Dancet added. These would include substances with carcinogenic, mutagenic or reprotoxic (CMR) properties or are persistent, bioaccumulative, toxic (PBT) in the environment or are endocrine disrupter chemicals (EDC).
However, improved information in dossiers could yield evidence that a chemical could be possibly toxic or be potentially harmful. There is a likelihood that substances that once did not seem to matter in terms of hazard could become ones that do.
ECHA is currently assessing a French government proposal that TiO2 be categorized as dangerous on its labels due to it being possibly carcinogenic through inhalation of its dust.
Currently, under the CLP regulation, administered by ECHA, the pigment is effectively categorized as a safe chemical without the necessity for a danger warning.
Once TiO2 is classified as being carcinogenic, it becomes automatically under REACH rules a substance of very high concern (SVHC), which will ultimately need it to have special authorization to be marketed in the EU.
After studying the evidence, probably next year, ECHA’s risk assessment committee, consisting of toxicologists appointed by the EU’s 28 member states, will recommend whether TiO2 should be labeled as hazardous. A final decision will then be made by the European Commission.
TiO2 is not the only substance with low solubility or insolubility faced with the threat of a hazard warning. Others include calcium carbonate, silicas and carbon black, all of which are used in inks or coatings. n
European Editor Sean Milmo is an Essex, UK-based writer specializing in coverage of the chemical industry.
This more conciliatory approach is coming as a relief to ink producers worried that the failure to register chemicals by some smaller companies by the mid-2018 deadline would leave them without some vital ingredients in their formulations.
The deadline is for the registration by producers or importers of chemicals with annual outputs of one to 100 tons – the last of three tranches with the other two larger volume categories having registration deadlines in 2010 and 2013.
The final group of chemicals covers two-thirds of the approximate total of 30,000 substances covered by REACH, which requires the registration of each chemical to be accompanied by a safety profile. The vast majority of registrants in 2018 will be SMEs, many of whom could find the registration of their products a burden on both their financial and human resources.
Some producers of pigments, additives and niche substances, particularly in countries outside Europe like China, have been warning that they may not register their low-volume products because the registration costs would eliminate their profits.
Chemicals not registered by producers or importers after mid-2018 cannot be sold in the EU market.
“We will make sure that substances critical for downstream sectors will be registered,” Geert Dancet, executive director of the Helsinki-based European Chemicals Agency (ECHA) - which administers REACH - told the annual assembly of the European Chemical Industry Council (Cefic) in Florence in October.
Cefic is Europe’s main trade association for the chemical industry, covering both bulk and speciality chemicals.
ECHA and the European Commission, the EU’s Brussels-based executive to which the agency is accountable, have also been giving other assurances on a number of other issues on REACH that have been worrying downstream sectors, particularly formulators of products like inks, coatings and adhesives.
Within the sector for printing inks and related products, a major anxiety has been the cost of obtaining safety data for inclusion in the REACH registration dossiers.
In addition, the dossiers have to contain information on the downstream use of chemicals. With inks, this information can be complicated, particularly with regard to how downstream workers might be exposed to dangerous substances.
Recently, a new concern for suppliers and users has been an increasing likelihood that chemicals previously regarded as being safe could be treated by the authorities as being dangerous.
There is already an outside possibility that this could happen with titanium dioxide (TiO2) under the EU’s Classification, Labelling and Packaging (CLP) regulation, which is being implemented in parallel with REACH. Products with TiO2 could then have to be labeled as being hazardous.
Another issue, which could have a safety impact in the longer term, is the health, safety and environmental (HSE) status of nano particles in inks, coatings and similar products.
Currently, HSE experts consider that there is insufficient data available to draw up an adequate safety profile of nanomaterials in inks, coatings and similar formulated products.
Risk assessment of mixtures of different substances within compounds and formulations is also regarded as being another challenge because in certain cases not enough is known about whether the chemicals interact in ways that could be hazardous.
With all these uncertainties, the prime purpose of REACH, which is the communication of safety information on each chemical along the supply chain, is being undermined.
“The experience so far is that there is insufficient and unstructured communication up and down the supply chain, (with) information down the supply chain being perceived by downstream users as difficult to use,” Dancet told the Florence meeting.
With so many unresolved problems, REACH will not be receding into the background after the final mid-2018 registration deadline. It will continue to pose dilemmas for chemical and formulation producers, like ink makers, as well as by end users “Overall REACH has worked, but there is still a lot of work to do,” Dancet said. “The journey continues,” he added, listing a number of objectives into the 2020s, including dealing with substances of the most concern because of their degree of hazard and setting up a closer partnership with industry.
The current priority remains sorting out of difficulties with the 2018 registration, particularly for SMEs.
With critical substances threatened by non-registrations, ECHA has agreed to allow users to act as importers so they themselves will arrange and finance the registration of the chemicals.
“The downstream users will themselves be given the opportunity to become the registrants,” explained Janice Robinson, product regulations director for the European Council of Paint, Printing Ink and Artists’ Colours Industry (CEPE), Europe’s main coatings trade association. The European Printing Ink Association (EuPIA) is part of CEPE.
ECHA may even be flexible with the May 31, 2018 registration deadline if downstream users need extra time to organize their own registrations of threatened key substances.
On the matter of SMEs in particular being charged excessive fees to obtain safety data for the registration of their chemicals, the EU has tightened up the rules on data sharing through a Data Sharing Implementing Act, which was approved earlier this year.
Data for registrations can be acquired through membership of groups of producers and importers for each chemical, called substances information exchange forums (SIEFs). The data can also be obtained by non-SIEF members by paying for a “letter of access” to SIEF data.
The objective behind the SIEF system is that each substance goes through a joint registration process – “one substance, one registration” – to avoid submission of dossiers with different sets of data.
Steps have also been taken to ease the task of providing information in dossiers on the use of chemicals by downstream users, which with inks would mainly be printers, but can also include formulators. For downstream users it is crucial that the correct information on their use of a chemical is included in its registration dossier.
ECHA has introduced a system of standardization of the use information on individual chemicals by giving sector associations like CEPE and EuPIA the task for drawing up and providing to suppliers uniform data on uses.
A similar system is being applied to information on what is called “exposure scenarios” describing conditions and possible risks under which end-user staff would be exposed to specific hazardous chemicals.
After the 2018 registration, ECHA has indicated that it will focus much more on improving the quality of data in existing dossiers, which could mean giving more details about uses and exposure scenarios. Registrants could be requested to give more accurate data in their dossiers.
The agency’s strategy would nonetheless be to “concentrate on substances that matter,” Dancet added. These would include substances with carcinogenic, mutagenic or reprotoxic (CMR) properties or are persistent, bioaccumulative, toxic (PBT) in the environment or are endocrine disrupter chemicals (EDC).
However, improved information in dossiers could yield evidence that a chemical could be possibly toxic or be potentially harmful. There is a likelihood that substances that once did not seem to matter in terms of hazard could become ones that do.
ECHA is currently assessing a French government proposal that TiO2 be categorized as dangerous on its labels due to it being possibly carcinogenic through inhalation of its dust.
Currently, under the CLP regulation, administered by ECHA, the pigment is effectively categorized as a safe chemical without the necessity for a danger warning.
Once TiO2 is classified as being carcinogenic, it becomes automatically under REACH rules a substance of very high concern (SVHC), which will ultimately need it to have special authorization to be marketed in the EU.
After studying the evidence, probably next year, ECHA’s risk assessment committee, consisting of toxicologists appointed by the EU’s 28 member states, will recommend whether TiO2 should be labeled as hazardous. A final decision will then be made by the European Commission.
TiO2 is not the only substance with low solubility or insolubility faced with the threat of a hazard warning. Others include calcium carbonate, silicas and carbon black, all of which are used in inks or coatings. n
European Editor Sean Milmo is an Essex, UK-based writer specializing in coverage of the chemical industry.
