EU Proposing New Chemical Exposure Limits
Earlier this month, the European Commission released two proposed directives to improve the protection of workers from health risks linked to exposure to lead and diisocyanates.
While the Commission is proposing to further lower the existing exposure limit for lead, the second directive is reportedly the first-ever limit values for diisocyanates.
“Today, we deliver on our commitment to better protect workers from lead by introducing drastically-reduced exposure limits. In addition, we propose, for the very first time, EU-level protective limit values for diisocyanates, which can cause asthma and other respiratory diseases,” said Nicolas Schmit, Commissioner for Jobs and Social Rights.
“This proposal will contribute to creating healthier and safer workplaces, and it will protect hundreds of thousands of workers across the EU, which is a key commitment under the European Pillar of Social Rights.”
About the Directives
According to the impact assessment conducted by the Commission, it is estimated that currently, 100,000 workers in the EU are exposed to lead at work. Approximately 300 cases of ill-health occur annually in the EU due to past exposure to lead, according to the Commission.
Today we deliver on our commitment to protect workers from health risks linked to exposure to dangerous chemicals.
— European Commission ???? (@EU_Commission) February 13, 2023
We propose to:
?? Lower exposure limits for lead
?? Introduce exposure limits for diisocyanates
This will contribute to creating healthier and safer workplaces.
Exposure reportedly occurs in the mining and primary processing of lead, including in products such as batteries. Additionally, workers can be exposed to lead due to its historical application in renovations, waste collection, recycling and environmental remediation.
On the basis of the latest evidence, the Commission proposes:
The assessment also found that 4.2 million workers in the EU are exposed to diisocyanates. Occupational exposure to diisocyanates accounts for 9% to 15% of all asthma cases in adults of working age.
Work-related exposure to diisocyanates occurs primarily in the manufacturing of polyurethane, which is used for products such as foams, plastics, coatings, varnishes, two-pack paints and adhesives.
Consequently, for the first time, the Commission is proposing to introduce limit values referring to the nitrogen, carbon and oxygen group of diisocyanates:
The Commission is also reportedly proposing “notations,” or indications added to limit values that alert employers and workers of possible exposure via routes other than inhalation and of the need to implement protective measures.
The Commission’s proposal will now be discussed by the European Parliament and the Council. If adopted, Member States will have two years to make transfer the directives into national law.
As there are currently no limit values for diisocyanates, the Commission also proposes a transitional period until Dec. 31, 2028, to support businesses with implementation. Prior to this implementation, the occupational exposure limit will be 10µg NCO/m3, and short-term exposure should be limited to 20µg NCO /m3.
Recent EU Titanium Dioxide Ruling
Last year, the Court of Justice of the European Union (CJEU) issued a press release announcing the annulment of the Commission Delegated Regulation of 2019 concerning the harmonized classification and labeling of titanium dioxide.
The annulment was reportedly delivered in a chamber setting in extended composition in three joined cases. There, the General Court annulled the contested regulation in so far as it concerns the harmonized classification and labeling of TiO2.
In its findings, the General Court first stated that in the present case, the requirement to base the classification of a carcinogenic substance on reliable and acceptable studies was not satisfied. This decision was reached as the result of a recent scientific study.
The study aimed to verify the degree of lung overload of TiO2 particles in order to properly assess carcinogenicity, whereas the RAC used a density value corresponding to the density of unagglomerated primary particles of TiO2.
The latter method is reported to always be higher than the density of the agglomerates of nano-sized particles of a substance.
According to the General Court, the RAC also failed to take into account all the relevant factors in order to calculate the lung overload during the scientific study at issue, stating that, “namely the characteristics of the particles tested in that scientific study, the fact that those particles tend to agglomerate and the fact that the density of the agglomerates of particles was lower than the particle density and that, for that reason, those agglomerates occupied more volume in the lungs.”
In its first conclusion, the EU found that the RAC’s findings that the lung overload in the scientific study at issue was acceptable were implausible. Consequently, in so far as, for the purposes of the harmonized classification and labeling of TiO2, the Commission based the contested regulation on the RAC Opinion and thus followed the RAC’s conclusion as to the reliability and acceptability of the results of the scientific study at issue, which constituted a decisive study for the classification proposal for titanium dioxide, it made the same manifest error of assessment as the RAC.
Secondly, the General Court found that in contesting the classification and labeling infringed the criterion according to which the classification of a substance as carcinogenic can apply only to a substance that has the intrinsic property to cause cancer.
Within that context, the EU stated that under Regulation No 1272/2008, harmonized classification and labeling of a substance as carcinogenic may be based only on the intrinsic properties of the substance which determine its intrinsic capacity to cause cancer.
By interpreting the concept of “intrinsic properties” the General Court stated that, “although that concept does not appear in Regulation No 1272/2008, it must be interpreted in its literal sense as referring to the ‘properties which a substance has in and of itself,’ which is consistent, inter alia, with the objectives and purpose of harmonized classification and labeling under that regulation.”
In addition to its recent findings and ruling, the General Court noted that the contested classification and labeling are intended to identify and notify a carcinogenic hazard of TiO2 which, in the RAC Opinion, was classified as “non-intrinsic in a classical sense.”
By observing TiO2 in this way—in that it refers to both an opinion and the contested regulation—the General Court further explained that the carcinogenicity hazard is linked solely to certain respirable TiO2 particles, when they are present in a certain form, physical state, size and quantity, it occurs only in lung overload conditions and corresponds to particle toxicity.
In conclusion, the General Court found if it were to uphold the conclusion contained in the RAC Opinion that the mode of action of carcinogenicity on which that committee relied could not be regarded as intrinsic toxicity in the classical sense, it would be committing a manifest error of assessment.
