European Commission s efforts in harmonising the testing and health based evaluation of construction products emissions in relation to CE marking

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1 European Commission s efforts in harmonising the testing and health based evaluation of construction products emissions in relation to CE marking Stylianos Kephalopoulos 1, Otmar Geiss 1, Natasha Grenier 2, Manfred Fuchs 4 1 European Commission, Joint Research Centre, Ispra, Italy 2 European Commission, DG Health and Consumers, Bruxelles, Belgium 3 European Commission, DG Enterprise and Industry, Bruxelles, Belgium * Corresponding stylianos.kephalopoulos@jrc.ec.europa.eu Keywords: harmonisation, indoor building products labelling, CE Marking, EU-LCI 1 Background Emissions from construction products can constitute a significant source of indoor pollution. A wide range of volatile organic compounds (s) and formaldehyde can be released, and concentrations can be particularly elevated in new buildings and following refurbishment. A number of national and industry focused labelling schemes for low emitting products exist in Europe and each has its own specific requirements for testing and criteria for product evaluation. This results in significant costs to industries wishing to provide low emitting products in different European markets and is also potentially confusing for building designers and consumers wishing to make informed choices among a variety of available products on the market. In response to this concern, and to further encourage the development and application of low emitting products, an EU expert group, co-ordinated by the European Commission s Joint Research Centre in Ispra (EC-JRC), was established to promote and seek consensus on the scope for harmonisation of the indoor material labelling schemes at EU level. This group published a report (ECA, 2005) that critically reviewed the characteristics of existing schemes, identified the main similarities and differences between them and recommended further steps towards convergence. Subsequently the aforementioned harmonisation initiative was promoted by a conference organised in the context of the German EU presidency in Berlin (UBA, 2007) and further taken forward by the ECA preparatory WG 27, co-ordinated by EC-JRC, which elaborated a harmonisation framework for indoor products emissions labelling in Europe. In the activities of this WG contributed representatives of the German and French evaluation systems (AgBB and AFSSET/ANSES correspondingly), the Danish (DICL), the Finish (M1) labelling schemes and also from emission test laboratories in the UK, France, Finland and Denmark have contributed to the activities of this WG. The need for harmonisation of labelling schemes for building products in the EU was also among the main recommendations issued by the DG RTD funded EnVIE co-ordination action on indoor air quality and health effects (EnVIE, 2008). This harmonisation activity is part of the agenda of the DG SANCO s expert group on Indoor Air Quality and actually coordinated by DG JRC in liaison with DG SANCO and DG ENTR. 2 Harmonisation framework for indoor products labelling schemes in EU 100 experts all over the world discussed and reached consensus about the principles a preliminary version of the harmonisation framework for indoor products labelling schemes in EU in the context of the EC Workshop on Harmonisation Framework for indoor material labelling schemes: challenge with a global perspective which was organised by DG JRC in liaison with DG SANCO and DG ENTR on 7-8 June 2010 in Somma Lombardo (Italy). Participants included representatives of the European Commission (i.e., DGs ENTR, SANCO and JRC), existing labelling schemes in Europe, USA, Canada and China, industry partners from various building sectors and their European federations, governmental organisations, standardisation bodies

2 and NGOs with a direct involvement and/or interest in labelling of building materials and consumer products. This harmonisation framework was further elaborated and recently published by DG JRC as ECA report no. 27 in 2012 (ECA, 2012). It consists of core and transitional criteria for testing and evaluation methodologies related to chemical emissions of indoor building products. Table 1. Consensus reached for the measurement methods, the core and the transitional criteria Requirements / Parameter Measuring method / Chamber Measuring points (days) Core criteria Single s evaluated (R = Ci/LCI <1)) Carcinogens evaluated according to concentration emitted M1 Finland DICL Denmark AgBB Germany AFSSET France Consensus Harmonised CEN Standard (based on ISO ) 28 3, 10 and 28 3 and 28 3 and 28 3 and 28 No IARC class 1 SERa < 5 µg/m 2 h T measured SERa < 200 µg/m 2 h Formaldehyde SERa < 50 measured µg/m 2 h Transitional criteria Compounds without LCI assessment ( notyet-assessed substances comparison with irritation threshold IARC class 1 R < LCIs (2010) EU classes 1 and 2 56 listed compounds Sum < 1 µg/m 3 R < LCIs (2009) EU classes 1 and 2 2 listed compounds < 1 µg/m 3 R < 1 Harmonised list of LCIs Harmonised list of EU carcinogens classes 1 and 2 compounds to be checked No 1000 µg/m µg/m µg/m 3 75 µg/m 3 No 1 10 µg/m 3 (LCI) Value to be discussed No No Sum < 100 µg/m 3 Sum < 100 µg/m 3 Sum < 100 µg/m 3 Other compounds Ammonia Aldehydes evaluated TS measured No No < 100 µg/m 3 No Await validation CEN TC 351 Sensory evaluation Acceptability Acceptability Yes (Pilot No Await untrained and intensity; phase using -28 panel 15 persons untrained panel, minimum 20 persons ISO/FDIS ) 1 Fomaldehyde measurement required for approval application at DIBt Common core criteria are those for which consensus has already been achieved and can be applied Europe-wide, whereas transitional criteria are those for which consensus is still to be reached and these continue to be applied locally during a transitional period. However, participating labelling schemes should follow the commonly agreed measurement methods for the transitional criteria. The criteria were established taking into consideration the results of round robin testing of products performed according to the individual labelling schemes and of the on-going work within the

3 Table 2. Common core and transitional criteria versus harmonised criteria for existing labeling schemes AFSSET Current criteria Core and transitional criteria Step I (1 to 2 years) Step II (ca. 5 years) (based on LCI) AgBB (based on LCI) - TS - TS DICL - Irritation - Formaldehyde and other aldehydes M1 - Formaldehyde - Ammonia

4 European standardisation body (CEN) to develop and validate a horizontal harmonised test method to determine the emission of potentially dangerous substances from construction products in support of requirements for health, safety and environment under the Construction Products Directive (89/106/EEC) and subsequent Construction Products Regulation (305/2011/EU, CPR). The consensus reached for the measurement methods, the common core and transitional criteria is shown in table 1 whereas the common core and transitional criteria for existing labelling schemes versus the harmonised criteria are shown in table 2. 3 The health based evaluation of chemical emissions from building products The health based evaluation of chemical emissions from the building products is integral part of the criteria proposed by the aforementioned harmonisation framework (EC-JRC, 2010). Actually a harmonisation process concerning the health based evaluation of the chemical emissions from building products is in place in Europe which is based on the LCI ( Lowest Concentration of Interest ) approach. This harmonisation process concerns around 170 indoor related chemicals and is coordinated by DG JRC on behalf of DG SANCO (EU-LCI project) in liaison with experts from the EU Member States. The EU-LCI work builds on firm foundations laid by the labelling schemes established by AgBB in Germany and ANSES in France that currently apply the LCI concept, as well as those in Finland and Denmark. Ultimately, this will allow voluntary and mandatory labelling schemes to evaluate product emissions in the same way using a robust health-based procedure and support the establishment of future emission classes for CE marking under the European Construction Products Regulation (CPR, 2011) with a harmonised list of LCI values. At present, only volatile organic substances (s) are being considered. Very volatile (Vs), semi-volatile organic compounds (Ss) and carcinogens are not considered at this stage of the process with the exception of acetaldehyde and formaldehyde. The EU-LCI harmonisation process has recently concluded its preparatory phase in which: 1. A robust protocol for establishing a harmonised list of compounds and their associated EU- LCI values was devised taking into account existing procedures used in some EU Member States. This procedure based on sound toxicological and risk assessment principles represents an appropriate health-protective, science-based, transparent and yet pragmatic approach for the evaluation of chemical emissions from building products. 2. A list of provisional EU-LCIs for some 110 substances which includes the 10 compounds relevant to DG ENTR s ad hoc group on classes (i.e., formaldehyde, acetaldehyde, toluene, tetrachloroethylene, xylene, 1,2,4-trimethylbenzene, 1,4-dichlorobenzene, ethylbenzene, 2- butoxyethanol and styrene) is under preparation. 3. A flexible framework that enables future revision of the content of the EU-LCI list in terms both of the type and number of compounds included and their associated EU-LCI values was elaborated which takes into account new knowledge (e.g. data resulting from the REACH implementation process or compounds identified and suggested by EU national authorities). The detailed protocol for the de novo derivation of EU-LCI values includes the following sections: a) Definition of EU-LCI b) Data Compilation Sheet All relevant toxicological data for each substance are assimilated into one table. This simplifies the identification of commonalities and differences and also guarantees the fundamental principle of transparency in deriving the EU-LCI values.

5 c) Fact Sheet To ensure that the derivation of EU-LCIs is transparent, a fact-sheet with standardised format is generated for each substance. This comprises four main sections: a) general information; b) toxicological database (values derived from the data compilation process described above); c) assessment factors and d) the derivation of the EU-LCI value. E) Rationale for the derivation of the EU-LCI. Parameters in the factsheet are accompanied when necessary by an explanatory note. Moreover the protocol provides instructions on how to deal with rounding, read-across and molar adjustment. The next step in the EU-LCI process foresees the setting up in the second half of 2012 of the EU-LCI Committee (comprising both experts and representatives nominated by the EU Member States and proposed by the European Commission) with the aim to formally establish EU-LCI values on the basis of the proposals of the EU-LCI preparatory WG. 4 The harmonisation framework for labelling schemes in relation to CE marking In 2011, the European Construction Products Regulation has replaced the Construction Products Directive of The goal of the CPR is to facilitate cross-border trade and over-come trade barriers in form of national rules and standards. The CPR regulation aims at providing a common technical language in harmonised European product performance standards, for use by manufacturers and regulators. Construction Products Directive (CPD) and Construction Products Regulation (CPR) contain a chapter defining the framework of European or national requirements for hygiene, health and the environment for construction works. Among others, giving-off of toxic gas, or by presence of dangerous particles or gases in the air has been identified as one specific criteria. The interpretation into limit values for pollutants is left to each EU member state and is currently implemented on a mandatory basis only in France and Germany. The purpose of the CPR is not to influence the level of protection but to harmonise the technical description of products, for facilitating cross-border trade. CE marking could (wherever relevant) be accompanied by performance classes that cover all national regulations in Europe. Then each EU member state can specify which performance classes a product shall fulfil for being accepted on that national market. The intention is that this CE marking will substitute any national law. The challenge is how the information on the product can be at best used for fit for purpose building constructions. This topic acquired high relevance for Europe when the French system was introduced recently since this system is based on performance classes as opposed to the German system which is based on pass/fail criteria. The current effort is to bring both systems into a harmonised form, however, for the time being only a merged form out of the two differing systems in Germany and France has been elaborated by DG ENTR under the framework of the CPR in Conclusions and recommendations The European Commission has been progressing in the development of a harmonisation framework in Europe concerning the emission testing and health based evaluation of indoor products emissions. When implemented this will allow industries providing low emitting products throughout the European Market at reasonable costs and also enable building designers and consumers making informed choices among the variety of building and other indoor related products available on the market Outstanding issues still to be resolved concern the establishment of harmonised criteria for: (a) the definition of emission performance classes of building products in the context of CE marking; (b) a common approach and an upper limit for T and (c) the evaluation of substances not having LCI values ( not-yet-assessed substances).

6 There is also the need to: (a) consider inclusion into the harmonisation framework of emerging pollutants such as S e.g. phthalates, flame retardants and require appropriate test methods; (b) reach consensus about a common list on carcinogens (EU list versus IARC list) and (c) to come up with a harmonised standard for sensory evaluation to complement the chemical assessment of product emissions. Last but not least, as this harmonization framework is cross-cutting various EU legislative mandates and standardization activities, it is important to have it implemented in a wider and integrated context of safe, healthy, energy efficient and sustainable buildings in EU. This, in line with Europe 2020 Strategy, implies the efficient alignment and implementation of various legislative mandates, such as, the Construction Products Directive (89/106/EEC) and the subsequent Construction Products Regulation (CPR, 2011), the Energy Performance of Buildings Directive EPBD (2002/91/EC), the EC Lead Market Initiative (COM(2007)860), the Integrated Product Policy (IPP), the Chemicals Policy (REACH), the Green Public Procurement, the Integration of Environmental Aspects into European Standardisation (COM(2004)206). 6 References Construction Products Directive (CPD, 1989). Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products; Official Journal L 040, 11/02/1989 P Construction Products Regulation (CPR, 2011). Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC. EnVIE WP4 Technical Report Policies on Indoor Air Quality: Assessment and Needs. EnVIE Co-ordination Action on Indoor Air Quality and Health Effects (Project no. SSPE-CT ), Report can be found at: European Commission - Joint Research Centre (EC-JRC) Proceedings of the EU Workshop on Harmonisation of the health based evaluation of emissions from building products in the EU using the LCI (Lowest Concentrations of Interest)-concept, September 2010, Ispra. ( ISO/FDIS :2011 (E) (Indoor air - Part 28: Determination of odour emissions from building products using test chambers). Kephalopoulos, S., Crump, D., Däumling, C., Winther-Funch, L., Horn, W., Keirsbulck, M., Maupetit, F., Säteri, J., Saarela, K., Scutaru, A.M., Tirkkonen, T., Witterseh, T., Sperk, C. ECA (European Collaborative Action Urban Air, Indoor Environment and Human Exposure ). Report No 27. Harmonisation framework for indoor product labelling schemes in the EU (2012) EUR EN Publications Office of the European Union. Kephalopoulos, S., Koistinen, K., Kotzias, D., Augustin, R., Cochet, C., Crump, D., De Oliveira Fernandes, Däumling, C., Loomans, M., Lundgren, B., Maupetit, F., Oppl, R., Pacary, T., Saarela, K., Seifert, B., Vankann, E., Witterseh, T., Wolkoff, P. ECA (European Collaborative Action Urban Air, Indoor Environment and Human Exposure ). Report No. 24. Harmonisation of indoor material emissions labelling systems in the EU, Inventory of existing schemes. EUR EN, Publications Office of the European Union. UBA International Conference on Construction Products and Indoor Air Quality, Berlin. June Federal Environment Agency. Report can be found at: df