OPINION of the French Agency for Food, Environmental and Occupational Health & Safety

Transcription

1 The Directr General Maisns-Alfrt, 26 Octber 2017 OPINION f the French Agency fr Fd, Envirnmental and Occupatinal Health & Safety n the risk assessment f ccupatinal expsure t prducts used fr nail care and decratin ANSES undertakes independent and pluralistic scientific expert assessments. ANSES's public health missin invlves ensuring envirnmental, ccupatinal and fd safety as well as assessing the ptential health risks they may entail. It als cntributes t the prtectin f the health and welfare f animals, the prtectin f plant health and the evaluatin f the nutritinal characteristics f fd. It prvides the cmpetent authrities with the necessary infrmatin cncerning these risks as well as the requisite expertise and technical supprt fr drafting legislative and statutry prvisins and implementing risk management strategies (Article L f the French Public Health Cde). Its pinins are published n its website. This pinin is a translatin f the riginal French versin. In the event f any discrepancy r ambiguity the French language text dated 26 Octber 2017 shall prevail. On 23 May 2014, ANSES received a frmal request frm the French Health Prducts Safety Agency (ANSM) t cnduct the fllwing expert appraisal n the risk assessment f ccupatinal expsure t prducts used fr nail care and decratin. 1. BACKGROUND AND PURPOSE OF THE REQUEST The expert appraisal wrk n substances classified as categry 2 reprtxic substances 1 and/r endcrine disruptrs (EDs), perfrmed by ANSES fllwing a frmal request frm the Directrate General fr Health (DGS) in 2009, included tluene. A health risk assessment fr this substance was therefre cnducted by ANSES and published in May Hwever, it did nt include an expert appraisal f the risks assciated with the pssible presence f tluene in csmetics, as this questin des nt fall within ANSES's scpe. Nevertheless, the reprt prduced by ANSES highlighted the use f tluene as an additive in csmetics, mainly in nail varnish. In 2009, at the request f the DGS, the ANSM had als assessed the health risk assciated with the use f tluene in csmetics, particularly in nail varnish, fr end users (cnsumers), withut hwever taking int accunt the ccupatinal risk. These assessments then led t the questin being raised f the ptential health risks fr wrkers carrying ut nail care and decratin activities. In additin, ther substances used by these wrkers, such as acrylic cmpunds r glues, fr example, may als be f cncern. 1 Accrding t Regulatin (EC) N 1272/2008 n classificatin, labelling and packaging f substances and mixtures (the CLP Regulatin) French Agency fr Fd, Envirnmental and Occupatinal Health & Safety, 14 rue Pierre et Marie Curie, Maisns-Alfrt Cedex Telephne: +33 (0) Fax: +33 (0) ANSES/PR1/9/01-06 [versin e] cde Ennv : ANSES/FGE/0037

2 The ANSM therefre made a frmal request t ANSES n 23 May 2014 t assess the health risks related t ccupatinal expsure t the prducts used fr nail care and decratin. This request did nt include any assessment f the health risks t wrkers with regard t csmetics ther than thse used fr nails, r any assessment f the health risks t cnsumers related t the prducts used in nail csmetics. 2. ORGANISATION OF THE EXPERT APPRAISAL The expert appraisal was carried ut in accrdance with French Standard NF X "Quality in Expert Appraisals General Requirements f Cmpetence fr Expert Appraisals (May 2003)". It falls within the scpe f the Expert Cmmittee (CES) n "Assessment f chemical risks f cnsumer items and prducts" (CES CONSO). ANSES entrusted the expert appraisal t several rapprteurs frm the CES CONSO ( mandate) and the CES "Assessment f the risks related t air envirnments" (CES AIR) ( mandate). The methdlgical and scientific aspects f the wrk were presented at nine sessins f the CES CONSO ( mandate) between 3 July 2014 and 6 July 2017, and three sessins f the CES AIR ( mandate) between 18 September 2014 and 11 May The wrk was als presented t the "Data Analysis Methdlgy and Strategy" wrking grup f the Natinal Netwrk fr Mnitring and Preventin f Occupatinal Diseases (RNV3P) n 23 July 2015, and t the wrking grup f the Txicvigilance Crdinatin Cmmittee (CCTV) n 27 April 2015 and 17 March The wrk was adpted by the CES CONSO ( mandate) at its meeting n 6 July ANSES analyses the links f interest declared by the experts prir t their appintment and thrughut the wrk, in rder t avid ptential cnflicts f interest with regard t the matters dealt with as part f the expert appraisal. The experts declaratins f interests are made public via the ANSES website ( The expert appraisal wrk cnsisted in: - describing the nail care and decratin ccupatins and activities; - describing the diseases assciated with the ccupatins, and the prducts and substances called int questin; - describing dermal and atmspheric expsures t the prducts and substances; - identifying the substances fund in the cmpsitin f the prducts and in the wrkplace air, and priritising the identified substances n the basis f the hazard (fr mre detail n the priritisatin methd fllwed, refer t Annex 1 f this pinin); - assessing the rder f magnitude f the atmspheric cncentratins f the substances fund in the wrkplace air and cmparing them with the ccupatinal expsure limit values r ther reference values; - issuing recmmendatins cncerning the substances and prducts used, the means f preventin and prtectin, training and infrmatin fr wrkers, medical mnitring, research rientatins t imprve knwledge, and mre bradly, the chemical safety f csmetics and ccupatinal expsure assessment in the csmetics sectr. Page 2 / 20

3 Data cllectin: Data were cllected using varius means: analysis and synthesis f the scientific literature, hearings and cnsultatins with stakehlders, extractin and explitatin f databases, questinnaire surveys and measurement campaigns. Hearings tk place with the fllwing stakehlders ver the perid : - representatives f prfessinal federatins r assciatins: the French Natinal Cnfederatin f Beauty Institutes (CNAIB) the French Federatin f Beauty Cmpanies (FEBEA) the Internatinal Federatin f Prfessinal Educatin in Perfumery and Beauty Csmetics (FIEPPEC) the Assciatin f Small and Medium Enterprises in the Csmetics Sectr (COSMED) the French Unin f Nail Prsthetists (SNSO) - the Ile-de-France Reginal Directrate fr Enterprises, Cmpetitin Plicy, Cnsumer Affairs Labur and Emplyment (DIRECCTE) - three physicians: Dr Marie-Nëlle Crépy, Dermatlgist at the Occupatinal Disease Cnsultatin Centre (CCPP) f the Hôtel-Dieu in Paris Dr Lynda Bensefa-Clas, Epidemilgist at the CCPP f the Hôtel-Dieu in Paris Dr Vincent Bnneterre, University Prfessr - Hspital Practitiner at the Grenble Alpes University Hspital Centre (CHU) Several cnsumer assciatins were cntacted and cnsulted in rder t btain infrmatin n any studies cnducted n the prducts used in nail care and decratin activities. An internatinal cnsultatin was carried ut with several institutes, assciatins, prfessinal federatins, agencies, r natinal authrities in the areas f health and/r ccupatinal safety (Eurpe and Nrth America). Data was extracted and prcessed frm several databases: the INRS's 2 COLCHIC database (database fr ccupatinal expsure t chemicals), the French database n prducts and cmpsitins (BNPC) f the pisn cntrl centres' infrmatin system, and the Eurpean Cmmissin's Csmetic Ingredients Database (COSING). These data were explited t identify the substances present in the cmpsitin f the prducts used by these wrkers and emitted int wrkplace air. A tripartite research and develpment agreement (CRD) was entered int between ANSES, the Métrple Nrd Occupatinal Health Unit and the INRS in rder t cnduct atmspheric sampling campaigns t identify the (semi)vlatile rganic cmpunds r (s)vocs, present in wrkplace ambient air and measure the rder f magnitude f (s)vocs and respirable particle cncentratins. This CRD als included a questinnaire survey f nail technicians in rder t characterise the study ppulatin and their wrking practices. Several ccupatinal disease surveillance netwrks were questined, including the RNV3P, the Dermat-Allerglgy Vigilance Netwrk (REVIDAL-GERDA), The UK Health and Occupatin 2 The French Natinal Research and Safety Institute fr the Preventin f Occupatinal Accidents and Diseases Page 3 / 20

4 Research Netwrk (THOR) and the German netwrk f the Berufsgenssenschaft für Gesundheitsdienst und Whlfahrtspflege (BGW). They cntributed t the descriptin f the diseases assciated with the nail care and decratin ccupatins and the identificatin f the prducts and substances called int questin. An analysis and synthesis f the scientific literature helped describe the diseases assciated with the nail care and decratin ccupatins, identify the prducts and substances implicated, and describe the dermal and atmspheric expsures t the prducts and substances. Studies published up t May 2017 were identified with a query n the PubMed search engine and using the bibligraphic reference lists f the studies identified with this query ("snwballing" technique). This crpus f studies published in peer-reviewed jurnals was supplemented by studies frm the grey literature and bks identified with the Ggle search engine. An extractin f statistical data frm the Natinal Health Insurance Fund fr Salaried Wrkers (CNAMTS) prvided indicatins such as the number f reprted ccupatinal diseases r the number f cases f temprary wrk disability. Scpe f the expert appraisal wrk: - wrkers that may carry ut nail care and decratin activities, namely nail prsthetists r stylists and beauticians-manicurists; - the prducts and substances used and applied during nail care and decratin activities; - the fllwing nail care and decratin activities: applicatin and remval f prsthetic nails and classic r semi-permanent varnish. Descriptin f the nail care and decratin activities: - Applicatin and remval f classic varnish: a manicure first invlves remval f the previus varnish, if necessary, then filing f the nails and care f the cuticles. An exfliating scrub may be applied, and the hands may be massaged and misturised. This is fllwed by plishing f the nails and applicatin f multiple layers f varnish (base-cat, varnish, fixer r tp-cat) and air drying. Varnish is taken ff with nail-varnish remver. - Applicatin and remval f semi-permanent varnish: the applicatin prcedure is identical t that f classic varnish. The semi-permanent varnish is typically presented in the frm f a methacrylic gel that is plymerised under a UV lamp. Semi-permanent varnish is remved either by saking the nails in acetne, r with acetne-saked cttn pads held in place n each nail. Sanding may als be carried ut. - Applicatin and remval f prsthetic nails several techniques are available: the resin technique generally invlves manufacturing an artificial nail by mulding it ver the natural nail. A pwdered pre-plymer mixed with a liquid cntaining methacrylic mnmers is applied with a brush. It frms a resin that plymerises and hardens in the air (selfhardening resin). Lastly, the prfessinal files and plishes the nails and may apply a varnish r ther persnalised "nail art" decratin. The resin is remved either by saking the nails in acetne, r with acetne-saked cttn pads held in place n each nail; the gel technique typically invlves several successive applicatins f a methacrylic gel that plymerises and hardens after each expsure under the lamp fr 2 t 3 minutes. As with the resin technique, the prfessinal then files and plishes the nails and may apply a varnish r ther "nail art" decratin. Remval requires the gel t be filed ff; the capsule technique, cnsisting in applying prefrmed capsules t the nail, and the glass fibre r silk technique, cnsisting in gluing small pieces f glass fibre r silk fabric directly Page 4 / 20

5 nt the nail r nt a capsule, may be used but are far less widespread. As with the resin and gel techniques, the prfessinal then applies a varnish r ther "nail art" decratin. 3. ANALYSIS AND CONCLUSIONS OF THE CES CONSO ( MANDATE) In view f all the infrmatin and data cllected and prcessed in the expert appraisal reprt (ANSES, 2017), the CES CONSO ( mandate) decided t grup tgether its cnclusin accrding t the majr themes addressed. With regard t the wrkers carrying ut nail care and decratin activities Nail care and decratin activities are carried ut by nail prsthetists and als by beauticians. Hwever, nt all beauticians carry ut nail care and decratin activities. A ttal f 4739 nail prsthetists were identified as registered in France with the Chamber f Trades as f 30 January Nevertheless, it is difficult t estimate the exact number f practising wrkers, as this activity is grwing strngly. These wrkers may have the status f emplyee r be self-emplyed, wrking in dedicated premises r at their custmers' hmes. This predminantly female ppulatin encmpasses every age grup, with the majrity being between 18 and 35 years f age. Field visits identified wrkers wh smetimes d nt have a gd cmmand f French, which culd affect their understanding f the preventin messages. N diplma curses are required t exercise this prfessin in France, but mst f the wrkers interviewed stated that they had fllwed training in the applicatin f prsthetic nails. This training has highly variable mdules and duratins that are nt harmnised. Accrding t the respnses t the questinnaire develped in the framewrk f the CRD, it seems that arund half f the wrkers have already been made aware f the health risks related t their activity. These wrkers are required t perfrm varius types f nail care and decratin activities, including applicatin f classic r semi-permanent varnish, manicures, applicatin f prsthetic nails using different techniques (gel r resin), and decratin f natural r artificial nails knwn as "nail art" r nail styling. The wrkers are mainly supplied by distributrs but als purchase their prducts frm central purchasing bdies, n the Internet, at trade fairs, r even in pharmacies, etc. Nail care and decratin establishments are generally small in size, ften with n mre than five peple. The visits t the establishments and the hearings revealed the lack f persnal and cllective prtective equipment. It shuld als be nted that sme f these wrkers carry ut their activities frm hme r at their custmers' hmes, making it even mre cmplicated/difficult t install cllective prtective equipment such as ventilated tables. Page 5 / 20

6 With regard t the substances Six hundred and ninety-six substances were identified in the cmpsitin f the prducts used r in the wrkplace air, illustrating the issue f wrker expsure t multiple chemical pllutants. These substances were priritised and ranked int three classes n the basis f their human health hazard classificatin r their inclusin n a list f endcrine disruptrs (EDs) 3 : Sixty substances are in the highest hazard class (classified as CMR, sensitiser and/r included n an ED list), including arund fifteen (meth)acrylates, phthalates, parabens, ketnes, aldehydes, alkanes, armatic alchls, silxanes, chlrine derivatives, armatic amines, benzene derivatives, terpenes, inrganic cmpunds, perxides, phsphrus derivatives, amides, derivatives f acids, and resins. Amng these substances fund t be f very high cncern, it shuld be nted that tw substances, dibutyl phthalate and n-hexane, are prhibited in csmetics accrding t Regulatin (EC) N 1223/2009. Ninety ther substances were cnsidered t be f cncern, including sme twenty aliphatic and alicyclic hydrcarbns, alchls, benzene derivatives, ketnes, etc. The ther substances are nt classified and were deemed t be f less cncern. Nt all the identified substances currently have a harmnised classificatin (CLP) with regard t sensitisatin. This is the case, fr example, with ethyl-2-cyanacrylate, reprted by the interviewed physicians as causing dermal sensitisatin and als mentined in the ccupatinal diseases table N 66 f the French general regime (RG66)f ccupatinal diseases, n ccupatinal rhinitis and asthma. Tluene is prhibited in csmetics except fr nail prducts. Hwever, the CES questins its technical value in these prducts, particularly since frmulatins are available that d nt cntain tluene. With regard t ccupatinal expsure The prducts used in nail csmetics and mainly implicated in expsures are prducts fr shaping artificial nails (gel, resin) cntaining (meth)acrylic mnmers that are ptentially sensitising, irritant and neurtxic. The slvents and thinners used may have similar prperties. Sme prducts cntain substances with reprtxic prperties, such as tluene and dibutyl phthalate, and substances with knwn, pssible r suspected carcingenicity, such as frmaldehyde, benzyl perxide and titanium dixide. The cncentratins f vlatile r semi-vlatile rganic cmpunds (VOCs r svocs) measured in the air at the wrk statin are lw cmpared t thse generally measured n industrial sites and are far lwer fr each substance than the values f the French ccupatinal expsure limits (OELs). Nevertheless, many (s)vocs may be present 3 Classificatin f the BKH ( substances_en.htm and substances_en.htm); Classificatin f the DHI ( Classificatin f the IEPA ( Sin List ( US EPA-EDSP ( assessments); TEDX list ( Page 6 / 20

7 simultaneusly, causing multi-pllutant expsure f wrkers t lw cncentratins f individual chemical agents whse effects are unknwn. Up t 42 (s)vocs have been identified n a single wrk premises. The cncentratins f ttal VOCs and tluene measured are high cmpared t thse measured in husing and in utdr air. Fr all chemical substances measured mre than 10 times in the wrkplace air f the investigated sites and in the absence f an OEL, the CES relied n different types f txicity reference values established by different rganisatins. The levels were bserved t have been exceeded fr acetaldehyde (present in mst f the situatins investigated), as well as fr acetne, and ethyl and methyl methacrylates. The different techniques implemented - gel, capsule r resin - have an impact n the nature and level f emissins. The "gel" technique seems t emit far fewer (meth)acrylates (e.g. ethyl methacrylate (EMA) and methyl methacrylate (MMA)) than the "resin" technique. Nail technicians are als expsed t particles frm the sanding f nails and resins. This dust has nt been characterised in detail, particularly in terms f its chemical cntent and particle size. The prtective measures fr preventing chemical risk, including general ventilatin, lcalised ventilatin such as ventilated² tables, and the wearing f glves and dust masks, seem t be rarely used by nail technicians. This is all the mre critical given that the wrking premises are usually small in size, less than 30 m², with the minimum area reprted as 5 m², which favurs the cncentratin f pllutants in the air f the rm if it is insufficiently ventilated. Ventilatin effectiveness varies accrding t the ventilatin systems used. Amng the pssible systems, the mst efficient and mst suited t the activity seems t be a lcalised suctin system such as a ventilated table cnnected t a filtratin system. A survey shwed that nne f the nail prsthetists used a filtratin system. Surgical masks may help prevent the transmissin f germs but prvide n prtectin frm vapurs and little r n prtectin frm fine particulate matter. Dust masks are effective at preventing the inhalatin f fine particulate matter emitted in particular during sanding peratins. If effective ventilatin is installed in the wrking envirnment, it des nt seem necessary t wear a cartridge filter mask. It is difficult fr nail technicians t prtect themselves by wearing glves during nail care and decratin peratins. Sme types f glves, such as nitrile glves, seem able t reduce the dermal expsure f wrkers t methacrylates alne, but the cncmitant handling f slvents r remvers such as acetne degrades these materials, thus reducing their effectiveness. With regard t ccupatinal diseases - Surveillance data n ccupatinal diseases in France Fr nail care and decratin wrkers in particular, surveillance data n ccupatinal diseases are limited, with the numbers f cases prbably underestimated, mainly fr the fllwing reasns: nail care and decratin invlve many self-emplyed wrkers and emplyees f VSEs, ppulatins that rarely receive medical mnitring as part f their jb, there is n specific activity cding fr nail care and decratin, manicure and pedicure, r the applicatin f prsthetic nails in the nmenclatures f ccupatinal activities. Page 7 / 20

8 The grups f ccupatinal diseases mst frequently diagnsed in these wrkers are: skin disrders, mainly including allergic cntact dermatitis (ACD), disrders f the respiratry tract and ENT, mainly including asthma, headaches, muscul-skeletal disrders, mainly including thse linked t prlnged and frequent sitting pstures and repetitive mvements f the hand, wrist r frearm. In mre than half f the cases, the diagnsed disease was attributed t expsure t the family f (meth)acrylates. The health prfessinals interviewed indicated that they used the ccupatinal diseases table N 82 (RG82) "Disrders caused by methyl methacrylate" fr cases cncerning expsure t (meth)acrylates ther than MMA. This raises the questin whether t expand the RG82 table t include disrders caused by all (meth)acrylates. - Data frm the scientific literature n ccupatinal diseases T ur knwledge, there have been n prspective lngitudinal epidemilgical studies (prspective chrt studies) amng nail care and decratin wrkers. General state f health Nail technicians declare themselves t be in gd health less frequently than female ffice wrkers accrding t a case-cntrl study. Accrding t a crss-sectinal survey, it seems that the frequency f nail technicians reprting a pr general state f health is higher amng thse applying nail csmetics cntaining (meth)acrylates. Accrding t a crss-sectinal study, the risk f ccurrence f reprted symptms (including headache, irritatin f the skin, nse and eyes, cugh and respiratry disrders) is higher amng the nail technicians mst expsed t VOCs. Skin diseases The risk f allergic cntact dermatitis (ACD) assciated with the expsure f these wrkers t nail csmetics, in particular thse cntaining (meth)acrylates, is well established. The ACDs caused by (meth)acrylates can be severe and imply an inability t wrk as a nail prsthetist r apply semi-permanent varnish. Several studies, particularly in Great Britain, have shwn an increase in recent years in the number f cases f ACD due t (meth)acrylic mnmers, related t their grwing use in the applicatin f artificial nails, in nail technicians as well as cnsumers. ACDs due t (meth)acrylates frm nail csmetics are amng the mst frequent ACDs due t csmetics. A retrspective analysis in Prtugal fr the perid shwed that (meth)acrylates were the main cause f the ACDs diagnsed in nail technicians, all ccupatinal sectrs cmbined. Nn-plymerised acrylic prducts are the mst allergenic, cmpared t finished plymerised prducts, which have lw allergenicity r are nn-allergenic. Nevertheless, sme prducts may be incmpletely plymerised and then release mnmers. Artificial nails made frm a mixture f liquid mnmer and pwdered (meth)acrylate plymer ("resin" technique) are the mst allergenic. Cmpared t the resin technique, the preferentially used gels and varnishes which are phtplymerisable reduce the risk f expsure t allergenic (meth)acrylic mnmers (e.g. 2-HEMA, 2-HMPA) 4 but severe cases f cntact allergy indicate that they are nt withut risk, including fr nn-prfessinal cnsumers. All 4 2-HEMA: 2-hydrxyethyl methacrylate; 2-HMPA: 2-hydrxyprpyl methacrylate Page 8 / 20

9 these types f prducts are nw available fr nn-prfessinal cnsumers, fr example in the frm f kits that can be purchased via the Internet. Nail csmetics are a surce f expsure t (meth)acrylates, which cntributes t the risk f sensitisatin f individuals. The acrylates and methacrylates mst frequently implicated in cases f ACD diagnsed in nail technicians (greater numbers f cases and highest prevalence f psitive patch tests) are 2-HEMA, 2-HEA, 2-HMPA, EGDMA, EA and EMA 5. Many crss-reactins are bserved between acrylates and methacrylates. Clinical case studies indicate that cyanacrylate glues can als be respnsible fr ACDs. Other skin disrders, such as irritant cntact dermatitis, have been dcumented amng nail care and decratin wrkers using nail csmetics cntaining (meth)acrylates, cyanacrylate glues, thinners and slvents. Skin burns are als pssible when mishandling ptentially caustic prducts such as acid liquid "primers". The incidence f skin infectins is higher in these ccupatins. Respiratry and ENT diseases Studies, including ne using brnchial challenge tests, indicate an increased risk f asthma amng wrkers applying artificial nails. An assciatin has been shwn between the duratin f cntact with acrylic nail csmetic prducts in nail technicians and an increase in respiratry tract inflammatin, as well as impairment f respiratry functin. While the adverse effects f MMA n respiratry health are well described, the fact that ther (meth)acrylates may prduce the same types f effects cannt be ruled ut. Cases f ccupatinal asthma related t cyanacrylate glues have als been reprted. Crss-sectinal studies indicate an increased risk f self-reprted respiratry and ENT symptms amng nail technicians cmpared t ffice wrkers: rhinitis, eye irritatin, thrat irritatin, cugh, respiratry irritatin, dyspnea and wheezing. Mre rarely, cases f hypersensitivity pneumnitis that can include extrinsic allergic alvelitis, smetimes assciated with a shrt but f high fever, have been bserved in nail prsthetists and were attributed t the txic impact f methacrylic mnmers used with the "resin" technique. Rare cases f pulmnary sarcidsis have als been reprted and were attributed t inhaled (meth)acrylates and fine particulate matter. Several studies have shwn that the respiratry disrders imprved r disappeared utside the wrk envirnment. Neurlgical effects Crss-sectinal studies, including tw case-cntrl studies, indicate an increased risk f headaches amng nail technicians. Accrding t ne study, these are mainly tensin headaches in peple wrking with the "resin" technique using (meth)acrylates. The headaches were frequently the reasn fr stpping the "resin" technique. Tw ther casecntrl studies did nt bserve any assciatin between this ccupatin and the headaches. Case-cntrl studies als indicate an increased risk f certain neurlgical disrders, including impaired cgnitive perfrmance, cncentratin difficulties, and impaired lfactry perfrmance. These disrders are typical f expsure t slvents in ther ccupatinal envirnments. 5 2-HEA: 2-hydrxyethyl acrylate; EGDMA: ethylene-glycl dimethacrylate; EA: ethyl acrylate; EMA: ethyl methacrylate Page 9 / 20

10 Adverse effects n reprductin and develpment Indicatins f an increased risk f adverse pregnancy utcmes and maternal cmplicatins assciated with nail care and decratin activities are weak and rely primarily n a retrspective study based n registers and an lder case-cntrl study. They require additinal research. Cancer There is n indicatin f any increased risk f cancer assciated with nail care and decratin activities. A single retrspective study based n registers examined the risk f cancer specifically frm manicures and did nt shw any significant assciatin with cancer. Other diseases Tw studies mentined pssible links between nail care and decratin activities and certain autimmune diseases. The risk f musculskeletal disrders is higher fr these ccupatins and mainly cncerns prlnged/frequent sitting pstures and repetitive mvements f the hand, wrist r frearm. Visual fatigue is als mentined by nail technicians. With regard t the chemical safety f csmetic ingredients and the ccupatinal expsure assessment Emplyers in France are subject t the requirement t search fr alternatives t CMR agents, as set ut in the general principles f preventin in Article L f the Labur Cde, and reinfrced by Article R transpsing the substitutin requirement established by Eurpean Directive 2004/37/EC by extending it at French natinal level t reprtxic agents. An industrial prduct with a frmaldehyde cntent greater than 0.1% wuld be classified as a carcingen, whereas cnversely a csmetic prduct with the same cntent wuld nt, as it is nt subject t the classificatin and labelling requirements laid dwn by the CLP Regulatin. The "Csmetics" Regulatin (EC) N 1223/2009 stipulates that prducts must be withut risk t the end user; the latter is defined in the regulatin as a cnsumer r prfessinal using the csmetic prduct. Mrever, the Csmetics Regulatin prhibits the presence f CMR substances in csmetics, except subject t a number f cnditins, including a favurable pinin f the Scientific Cmmittee n Cnsumer Safety (SCCS) f the Eurpean Cmmissin's Directrate General fr Health. Certain CMR substances have received a favurable pinin frm the SCCS, such as frmaldehyde, fr example, which is currently authrised in nail prducts at cncentratins f up t 5%. The use f this substance in hardeners fr nails was recently the subject f a re-assessment by the SCCS, which issued a favurable pinin up t a maximum cntent f 2.2%. S far, the Eurpean Cmmissin has nt updated Annex III f the Csmetics Regulatin t take this pinin int accunt. Occupatinal expsure is nt currently taken int accunt in the framewrk f the chemical safety assessments fr csmetics carried ut by the SCCS. Fr example, the SCCS assessment cnducted n frmaldehyde in hardeners fr nails n 16 December 2014 did nt take ccupatinal expsure int accunt. Hwever, it shuld be remembered that the cmpany placing the csmetic n the market is required t carry ut an assessment f the risks t end users including wrkers. Page 10 / 20

11 Cmpliance with the OELs fr substances identified as respiratry sensitisers des nt guarantee prtectin fr wrkers with regard t sensitisatin and respiratry allergy, because OELs are nt generally established n these effects and it is rarely pssible t derive OELs because a threshld belw which n sensitising effect is bserved cannt be determined. Recmmendatins f the CES With regard t the chemical substances emitted by r cntained in the prducts used by nail technicians The CES recmmends: Rapidly eliminating the use f plymerisable (meth)acrylic mnmers at the wrk statin (semi-permanent varnish, "resin" technique, gel technique), given: the txic and, amng thers, sensitising prperties f (meth)acrylic mnmers, with several f them being classified as skin sensitisers accrding t the CLP Regulatin (Skin Sens. 1); the risks highlighted in the scientific literature related t their uses in nail csmetics, in particular the risks f sensitisatin and skin allergy; the increases reprted in recent years in sme Eurpean cuntries in the number f cases f ACD due t (meth)acrylic mnmers, related t their grwing use in the applicatin f artificial nails, in bth nail technicians and cnsumers; the prtective measures such as ventilatin, wearing glves, and masks fr prtectin against dust, which rarely seem t be used by nail technicians. Substituting acetaldehyde by anther less hazardus substance, due t its C1B classificatin adpted by the Risk Assessment Cmmittee (RAC) f the Eurpean Chemicals Agency (ECHA) in 2016, and the measured expsures. Encuraging the eliminatin f tluene frm nail csmetics, given: the txic and reprtxic prperties f tluene, which was classified as txic fr reprductin accrding t the CLP Regulatin (R2); the fact that nail varnishes withut tluene have been identified. Adding ethyl-2-cyanacrylate (CAS N ) t ANSES's wrk prgramme fr identified substances, in rder t submit a dssier fr harmnised classificatin at Eurpean level, as this substance des nt currently have any harmnised classificatin fr the sensitisatin aspects. Mrever, the CES reiterates that with regard t ccupatinal expsure in France, in additin t the R1B classificatin f frmaldehyde r f mixtures required t be classified in applicatin f the CLP Regulatin, wrk invlving frmaldehyde expsure is classified as carcingenic 6 and is therefre subject t the substitutin requirement under the Labur Cde. With regard t the chemical safety f csmetic prducts and ccupatinal expsure assessment The CES recmmends: Systematically taking int accunt an assessment f the risks fr wrkers in the framewrk f the chemical safety assessments fr csmetic ingredients carried ut by the SCCS, in particular fr ingredients reserved fr prfessinal use; 6 Order f 13 July 2006 amending the Order f 5 January 1993 listing carcingenic chemical substances, preparatins and prcesses within the meaning f the secnd paragraph f Article R f the Labur Cde Page 11 / 20

12 Ensuring that the risk assessments fr wrkers are actually available when checks n the cmpanies respnsible fr placing the csmetics n the market are carried ut by the cmpetent authrities; Drafting a methdlgical guidance dcument equivalent t that f the SCCS 7 fr assessing expsure and the risks fr wrkers expsed t csmetics. With regard t the means f preventin and prtectin t be implemented The CES recmmends: Installing ventilated tables: extractin as clse as pssible t the emissin surces via the ventilated tables, in rder t effectively capture the vapurs and dust. They shuld be psitined t take accunt f the directins f emissin f the sanding dust, with sufficient air speeds at the cllectin grid, and the venting f filtering discharge t the utdrs whenever pssible; regular replacement f the active carbn filters in the ventilated tables, in accrdance with the manufacturers' recmmendatins. Wearing a dust/gas/vapur mask with an A1P2 filter, r failing this a P2 type dust mask, in particular when applying/remving prsthetic nails and sanding natural r artificial nails, in the absence f effective ventilatin at the wrk statin (e.g. ventilated tables); Wearing nitrile glves t apply prsthetic nails, and changing them at least fr each peratin r whenever they becme trn r hled, t reduce dermal expsure t (meth)acrylates; Taking the ergnmic aspects int accunt in the design and layut f wrk statins; String new prducts in a dedicated enclsed area that is separate frm meal areas; Dispsing f all waste in a bin with a self-clsing lid; Washing hands befre and after each custmer and befre and after meals (this is already stipulated by the Labur Cde), and cleaning the equipment and wrk statin befre and after each custmer; Clearly labelling and identifying the cntents f repackaged prducts; Implementing a recvery prcedure fr the prduct(s) in the event f spillage; Eliminating the use by the general public f plymerisatin devices fr manufacturing prsthetic nails and applying semi-permanent varnish; Encuraging the placing n the market f "n-tuch" prducts/techniques, like thse already used in industry and by dental prsthetists. The CES suggests relying n the existing guides drafted by the NIOSH 8 and the US EPA 9 in rder t transcribe the key pints in the frm f brchures fr wrkers, like the ne prvided jintly by the RSI 10, Grenble University Hspital, the CNAMTS, the RNV3P and the University Jseph Furier. 7 The SCCS ntes f guidance fr the testing f csmetic ingredients and their safety evaluatin 9th Revisin 29 September An Evaluatin f Lcal Exhaust Ventilatin Systems fr Cntrlling Hazardus Expsures in Nail Salns Department f Health and Human Services CDC NIOSH September Prtecting the Health f Nail Saln Wrkers US EPA March Scial security scheme fr self-emplyed wrkers Page 12 / 20

13 With regard t the training and infrmatin f nail technicians The CES recmmends: Making it mandatry fr any persn required t apply prsthetic nails t fllw harmnised diplma curses, including a mdule n ccupatinal risk preventin and gd wrking practices; Prducing multilingual tls prviding infrmatin n ccupatinal risks and making them available t nail technicians; Ensuring that any prduct sheet available n the Internet includes a sectin n gd practices fr use, in additin t the technical descriptins f the prduct. With regard t the medical mnitring f nail technicians The CES recmmends extending the RG82 ccupatinal diseases table entitled "Disrders caused by methyl methacrylate" t include all methacrylates. With regard t research rientatins fr imprving knwledge The CES recmmends: Imprving knwledge n the effects and expsure, particularly regarding inhaled particles during sanding and filing peratins; Imprving knwledge n the ccupatinal diseases and assciated expsure f nail technicians, by setting up a prspective lngitudinal study t assess, amng ther things, the effects n sensitisatin and reprductin and develpment. In additin, sme results frm the literature seem t call fr further studies t better characterise the risk, fr example n a pssible link with autimmune diseases; Taking the sensitising effects int accunt when develping OELs fr substances classified as Categry 1 respiratry r skin sensitisers accrding t the CLP Regulatin. 4. AGENCY CONCLUSIONS AND RECOMMENDATIONS The French Agency fr Fd, Envirnmental and Occupatinal Health & Safety endrses the cnclusins and recmmendatins f its CES. In additin, the French Agency fr Fd, Envirnmental and Occupatinal Health & Safety wishes t raise awareness amng the different stakehlders identified in this study as able t help imprve preventin f the risks t wrkers expsed t the prducts used in nail care and decratin activities. T this end, it recmmends in particular: T cmpanies marketing csmetics intended fr nail care and decratin activities In the shrt/ medium-term, implementing the develpment and/r replacement f prducts intended fr nail care and decratin activities s as t eliminate expsure t the surces f varius hazardus chemical agents, in particular plymeriserable (meth)acrylic mnmers, tluene, acetaldehyde, etc.; then, develping "n-tuch" prducts/techniques, in cases where substitutin f the hazardus agent may nt be technically pssible; Page 13 / 20

14 Prviding the nail technicians with the necessary infrmatin cntained in the chemical safety reprts f the csmetics these cmpanies prduce, t enable the nail technicians t establish their "single dcument n ccupatinal risk assessment" (DUER) n a wellinfrmed basis; Supplementing any prduct sheet presenting the technical descriptins f the prduct available, including n the Internet, with a sectin n gd practices fr use. T wrkers carrying ut nail care and decratin activities Strengthening the implementatin f the general principles f preventive measures applicable regarding chemical risk, in rder t minimise the risk f expsure t hazardus chemical agents: by designing and rganising suitable wrking methds; by substituting, as a pririty, the chemicals used in the cmpsitin f csmetics intended fr nail care and decratin activities that are classified Categry 1A and 1B carcingenic, mutagenic and txic t reprductin accrding t the CLP Regulatin; by replacing the use f hazardus prducts by nn-hazardus r less hazardus prducts, fr example, by eliminating the use f prducts leading t expsure t (meth)acrylic mnmers ("resin" technique, "gel" technique, semi-permanent varnish); by setting up prtective equipment such as ventilated tables; by making suitable persnal prtective equipment available t avid expsure t the chemicals fund in the prducts used and particularly with a view t prtecting the skin and eyes; fr example: wearing and frequently replacing nitrile glves when using prducts invlving expsure t (meth)acrylic mnmers ("resin" technique, "gel" technique, semi-permanent varnish); in the absence f effective ventilatin at the wrk statin (e.g. suctin tables), wearing a dust/gas/vapur mask with an A1P2 filter, r failing this a P2 type dust mask, when applying r remving prsthetic nails and sanding artificial r natural nails; by implementing prvisins ensuring safety during the handling, strage and transprt f chemical agents and waste cntaining such agents (strage in dedicated premises, dispsal f waste in a bin, labelling and identificatin f repackaged prducts, etc.); by implementing apprpriate hygiene rules such as washing hands befre and after each custmer and befre and after each meal, as well as cleaning the equipment and wrk statin befre and after each custmer; Obtaining supplies preferentially frm cmpanies marketing/distributing prducts fr which safety data and practices t be cmplied with during use are available. Page 14 / 20

15 T the public authrities Rapidly sending this pinin t the SCCS with a view t cnducting a Eurpean assessment f the safety f nail csmetics cntaining (meth)acrylic mnmers fr cnsumers and wrkers; Implementing measures t ensure that: the assessment f the risks t wrkers is systematically taken int accunt in the framewrk f the chemical safety assessments fr csmetic ingredients carried ut by the SCCS; t this effect, drafting a methdlgical guide equivalent t that f the SCCS 11 fr assessing expsure and the risks fr wrkers expsed t csmetics wuld be welcme; the assessments f the risks fr wrkers are actually available during the cntrls carried ut n the cmpanies respnsible fr placing the prducts n the market; the best pssible risk management measures are implemented rapidly t avid the allergic cntact dermatitis assciated with the use f plymerisable (meth)acrylic mnmers, bth fr wrkers and cnsumers. Making it mandatry fr any persn required t apply prsthetic nails t fllw harmnised diplma curses, including a mdule n ccupatinal risk preventin and gd wrking practices; Revising the RG82 ccupatinal diseases table entitled "Disrders caused by methyl methacrylate" in rder t extend it if pssible t include all methacrylates; Adding ethyl-2-cyanacrylate t the wrk prgramme fr identified substances, in rder t submit a dssier fr harmnised classificatin at Eurpean level, as this substance des nt currently have any harmnised classificatin fr the sensitisatin aspects; Taking the sensitising effects int accunt when develping OELs fr substances classified as Categry 1 respiratry r skin sensitisers accrding t the CLP Regulatin. T research and preventin institutins and rganisatins Imprving knwledge n effects and expsure, especially regarding inhaled particles during sanding and filing, and in particular n the txicity f these particles when these peratins are perfrmed n artificial nails made frm (meth)acrylates; Imprving knwledge n the state f health f nail technicians and hw it evlves, regarding amng ther things the risks f sensitisatin, allergic cntact dermatitis, asthma, adverse utcmes in terms f reprductin and develpment, neurlgical disrders, autimmune diseases and even cancer; Develping and disseminating multilingual tls that prvide infrmatin n preventin f the risks incurred by nail technicians, relying in particular n existing dcuments. Dr Rger GENET 11 The SCCS ntes f guidance fr the testing f csmetic ingredients and their safety evaluatin 9th Revisin 29 September 2015 Page 15 / 20

16 KEYWORDS Nail; nail prsthesis; manicure; meth(acrylate); varnish/plish; resin; gel; metrlgy; ccupatinal hygiene REFERENCES ANSES (2017) Evaluatin des risques des prfessinnels expsés aux prduits utilisés dans les activités de sin et de décratin de l ngle [Assessment f the risks fr prfessinals expsed t prducts used in nail care and decratin activities]. Cllective expert appraisal reprt f the French Agency fr Fd, Envirnmental and Occupatinal Health & Safety, July Page 16 / 20

17 ANNEX 1: METHOD USED FOR CHEMICAL SUBSTANCES PRIORITISATION FOR THE EXPERT APPRAISAL Six hundred and ninety-six substances were identified in the cmpsitin f the prducts used r in the wrkplace air. A methd fr priritising substances based n the hazard criterin was used t identify the substances psing a risk, dividing them int three grups. It shuld be nted that there were insufficient expsure data available t perfrm a risk assessment. In the absence f sufficiently representative expsure data fr all the identified substances and f specific tnnage data n the substances identified fr the nail care and decratin activities, the substances were priritised nly n the basis f the hazard. The harmnised classificatin fr each substance was used when available. Otherwise, the methd used the classificatin ntificatins accrding t the Regulatin n classificatin, labelling and packaging f substances and mixtures (CLP) 12, the classificatin f the Internatinal Agency fr Research n Cancer (IARC), r the classificatin f the US EPA. It was als specified fr each substance whether it was included n nn-regulatry lists f ptential endcrine-disrupting substances prpsed by Eurpean r internatinal rganisatins 13 (see Figure 1). 12 Regulatin (EC) N 1272/2008 f the Eurpean Parliament and f the Cuncil f 16 December 2008 n classificatin, labelling and packaging f substances and mixtures (CLP). 13 These are the lists f the BKH r the DHI, the Sin List, in the "Endcrine Disruptrs Screening Prgram Tier 1 Assessments" f the US EPA, in the "Endcrine Disruptrs Strategy" reprt f the Illinis Envirnmental Prtectin Agency (IEPA), r n the TEDX List as endcrine disruptrs. These are lists used by the teams wrking n endcrine disruptrs at ANSES. Page 17 / 20

18 Diagram 1: Chemical substances priritisatin methd based n hazard classificatin Substances identified Substances - CMR 1A, 1B r IARC 1, 2A, 2B r US-EPA knwn, likely, A, B1 r B2 carcingen - r included n ne f the lists as "prven/ptential" ED (BKH-cat.1 r DHI-cat.1 r SIN-3rd cat endcrinedisrupting chemicals r US EPA EDSP-Ptential r IEPAknwn) - r respiratry r skin sensitisers (Resp. Sens. 1 r Skin Sens. 1) Other substances Substances withut CLP classificatin, US- EPA pssible r suggestive carcingen, "suspected" ED (BKH-cat 2, DHI cat 2, TEDX list r IEPA prbable/suspected) Substances withut classificatin ntificatins CMR 1A, 1B, Skin Sens. 1, Resp. Sens. 1 Substances with classificatin ntificatins CMR 1A, 1B, Skin Sens. 1, Resp. Sens. 1 Substances with CLP classificatin, US-EPA pssible r suggestive carcingen, "suspected" ED (BKH-cat 2, DHI cat 2, TEDX list r IEPA prbable/suspected) Substances withut classificatin ntificatins CMR 1A, 1B, Skin Sens. 1, Resp. Sens. 1 Substances ranking based n hazard classificatin Pririty 1 substances analysis f regulatry tls t reduce expsure Pririty 3 substances Pririty 2 substances recmmendatins t be determined n a case-by-case basis (examples: prpsed classificatin, in-depth HRA, dcumentatin f expsure, etc.) All the substances in pririty grup 1 were cnsidered in the analysis f the results. The substances in pririty grup 2 were ranked. This cnsisted in assigning a scre t each ne. This scre was calculated accrding t the methd f Lithner et al. (2011) as amended (the initial Lithner et al methd invlved assigning a scre relying nly n the harmnised CLP classificatin). Fr the purpses f this request, it was decided t als incrprate the US EPA's carcingenicity classificatins int the scre calculatin (except thse classificatins used fr pririty grup 1) and a given substance's inclusin n ne f the lists as a "suspected" endcrine disruptr, fr which a scre was assigned. The substances in pririty grup 3 did nt underg any additinal prcessing r specific analysis. Page 18 / 20

19 Substances in pririty grup 1 60 substances were identified in pririty grup 1, 17 f which were frm detectins in wrkplace air. These substances included arund fifteen (meth)acrylates, phthalates, parabens, ketnes, aldehydes, alkanes, armatic alchls, silxanes, chlrine derivatives, armatic amines, benzene derivatives, terpenes, inrganic cmpunds, perxides, phsphrus derivatives, amides, derivatives f acids, and resins. Amng the substances in pririty grup 1: 15 are classified as carcingens (accrding t the CLP Regulatin, the US EPA r the IARC); 1 is classified as mutagens accrding t the CLP Regulatin; 2 are classified as txic fr reprductin accrding t the CLP Regulatin; 18 substances are included n lists f ptential ED substances; 30 substances are classified as skin sensitisers (mstly acrylates and methacrylates); 2 are classified as respiratry sensitisers. Substances in pririty grup 2 Ninety-fur substances were identified in grup 2, including sme twenty aliphatic and alicyclic hydrcarbns, alchls, benzene derivatives, acids, ketnes, etc. Amng these 94 substances, fur have a hazard scre > , an arbitrary threshld chsen in rder t present here nly the substances with the highest hazard scre. The hazard scres f the ther 90 substances were between 10 and 150. Amng the substances with a scre > 100, 33 were frm detectins in wrkplace air. Substances in pririty grup 3 The 542 remaining substances were classified in pririty grup 3. These chemical substances have n hazard criteria justifying their inclusin in pririty grups 1 and 2. Nevertheless, it shuld be nted that n exhaustive literature searches n the hazards f these substances were carried ut, and the fact that these substances belng t grup 3 des nt mean that they are nt hazardus t human health. Amng these 542 substances, 91 were detected in wrkplace air. It shuld be nted that several (meth)acrylates were identified in grup 3 despite having classificatin ntificatins, mainly as skin sensitisers. The relevance f these ntificatins was nt investigated. All the detailed results f the priritisatin methd are available in the expert appraisal reprt. Fr all the substances detected mre than 10 times in wrkplace air, and which are fund in the COLCHIC database and in the CRD measurement campaign, the decisin was made t: identify the number f cncentratin values abve the French r Eurpean regulatry 8h- OELs (thse in the COLCHIC database); calculate the rder f magnitude f the ratis between the cncentratin values and the French r Eurpean regulatry 8h-OELs (thse identified in the CRD measurement campaign). Fr all the substances detected in wrkplace air, it was decided t carry ut the same wrk cnsidering ther reference values (RVs) fr chrnic inhalatin expsure selected frm amng the OELs (excluding French r Eurpean regulatry OELs), txicity reference values (TRVs) adjusted fr an ccupatinal ppulatin, and Derived N-Effect Levels (DNELs) fr wrkers r adjusted fr an ccupatinal ppulatin and develped by ECHA's Risk Assessment Cmmittee. This enabled substances with n French r Eurpean regulatry 8h-OEL t be cmpared with an RV. Fr all the substances, this wrk made it pssible t cnsider RVs prtecting frm reversible r mre 14 By decreasing hazard scre, these substances are crtnaldehyde, acrlein, methanl and tluene. Page 19 / 20