Document jNyzMavzB0aEVbMvwj8MwrZR2

Ref. Ares(2023)2188876 - 27/03/2023 Extension of the GRA to professionals FEICA examples 13 May 2022 Potential impacts The extension of the GRA to additional hazard classes will potentially affect an enormously number of uses A large proportion of these uses are performed by professional users There is a risk that adhesives and sealants - without any significant risk in practice - will be banned without risk assessment 13/05/2022 5 Potential impacts Two examples: Product with a hazardous component used safely by professionals - brief mention to the diisocyanates training Questionnaire with professionals end users on experience with safety assessment 13/05/2022 6 OCF example OCF: - moisture curing One Component polyurethane Foams dispensed from pressurised containers. - typically used for gap filling, sealing, bonding, insulating for general construction and renovation purposes. - in most EU countries polyurethane (PU) foam is the standard installation/joining material to seal around windows in construction, due to its top insulation performance for energy efficient construction. - European OCF manufacturers estimate that over 100.000.000 cans of PU foam are used in the EU every year by well over 500.000 professional end users. One-component polyurethane chemistry is a chemistry based on isocyanate-functional polymers which can react with ambient moisture to form the cured polymer. 13/05/2022 7 OCF example The hazard of OCF is driven by the monomeric isocyanate (MDI), which is classified as respiratory sensitizer and may cause an allergic skin reaction . Dermal exposure assessment: Under the conditions described for its intended use, there is no dermal contact. - Skin contact is avoided by the design of the can - Product cures in minutes - PPE's are worn (gloves) Inhalation exposure assessment: - measurements of MDI on OCF products, containing approximately 15% of MDI monomer, were approx. 83 times below the Occupational Exposure Limit applicable at the time and even below the new proposed OEL (after 2029): - These results of the measurements are realistic applications, in realistic environments. The results obtained show an extremely low inhalation exposure In the theoretical extremes, with high volumes extruded in a short time, and a large surface in contact with air (which is not intended in real applications), results are also extremely low, clearly because MDI is not a volatile substance at room temperature. 13/05/2022 8 OCF example Measurement results Data measurement on site A - Window and door installation Operator Installation 2 doors/5 windows B - Window installation Installation 13 windows C - Window and door installation Data measurement including laboratory D - Laboratory and on construction site floor* Installation 8 windows/1 door Operator Extrusion of 30 cans of foam (17 in laboratory and 13 on site) E - Laboratory Extrusion of 10 cans (two times batches of 5 cans of foam) Sampling 24 minutes extrusion 16 minutes extrusion 30 minutes extrusion Sampling 30 minutes extrusion 36:30 and 32:20 minutes extrusion Measurements are well below the OEL Worst case results measured 0,00079 mg/m MDI Result spread over Average 8 hours 0,00004 mg/m MDI 0,00009 mg/m MDI 0,000002 mg/m MDI 0,00046 mg/m MDI 0,00003 mg/m MDI Detection level 0,0005 mg/m MDI 0,0005 mg/m MDI Results above detection limit Only 1 out of 8 measuring devices gave a result above detection limit: 0,0006 mg/m MDI Out of 7 measuring devices, none gave a result above detection limit *These conditions were highly unrealistic scenarios Typical scenario under which OCF is used: A team of two people would install typically 5-10 windows/doors a day, translating into up to 3 cans. Worst case scenario: 13/05/2022 The worst-case scenario based on our description would be a 12 can usage in one day, indoors, and cleaning the gun on that same day. A theoretical maximum of 30-40 average sized windows/doors installed a day amounts to 10-12 cans a day. 9 OCF example Because data measurement D and E (laboratory and on construction site floor) in the table were measured over a larger number of cans with a sampling time much higher than the surface curing time of the first extruded foam cans, it is also clear that inhalation exposure does not increase during curing of the foam. This is again not surprising in view of the low vapour pressure of MDI. Curing time: the formula contains a catalyst in a highly reactive pre-polymer, because it is designed to cure in minutes. All remaining monomers therefore will cure accordingly. OCF products typically have formed a tack free surface within 10 minutes, and in extreme conditions (very low temperature and humidity) it can take up to 1 hour 13/05/2022 10 The OCF example The OCF is one of many examples of products with safe use for professionals Under the conditions described for this intended use, we can conclude that OCF products intended for gap filling, sealing, bonding, insulating for general construction and renovation purposes, constitute an intrinsically safe product/use combination. This example and the measurements indicate that it is not justified to generally ban products based on their hazards, like respiratory sensitizing properties and/or based on professional use. Safe use can be guaranteed. It is important to take into account that the type of use is already safe. It is disproportionate to ban such type of use without a risk assessment 13/05/2022 11 Examples level of protection professional users Types of companies - Applications in the construction sector, e.g. resins injection, refurbishment, waterproofing - Application of flooring adhesives, e.g. parquet laying - Furniture production, e.g. kitchen furniture Present in different EU Member states: Belgium, Sweden, Spain, Germany, Denmark, France, Netherlands, Luxembourg 13/05/2022 12 Measures in place 92% of the respondents carried out a risk assessment when chemicals are handled in the workplace 92% of the respondents derive information on the safe use of chemicals from SDS, 72% from labels, 16% exposure scenarios, 68% own workplace assessments 96% of the respondents use protective gloves, 92% use googles, 72% protective clothing 13/05/2022 13 Training levels 40% of the employees followed external vocational training 68% of the employees went through internal training at the time of employment 76% of the employees go through regularly repeated internal training 76% of the employees receive task specific training 44% of employees benefit of written workplace specific instructions 13/05/2022 14 The diisocyanates training As of 24 August 2023, training is required for all professional and industrial users of products with a total monomeric diisocyanate concentration of > 0.1%. A comprehensive training programme was launched to ensure the safe use of diisocyanates for producers and professional users all over Europe. In this way, these Downstream Users ensure that all end-users of PU containing products across Europe continue to handle diisocyanates safely across Europe. Under the conditions described for this intended use, we can conclude that OCF products intended for gap filling, sealing, bonding, insulating for general construction and renovation purposes, constitute an intrinsically safe product/use combination. This example and the measurements indicate that it is not justified to generally ban products based on their hazards, like respiratory sensitizing properties and/or based on professional use. Safe use can be guaranteed. It is important to take into account that the type of use may already be safe. 13/05/2022 15