Ordinance No 13 dated 30.12.2003 onprotection of workers from the risks related to chemical agents at work
Issued by theMinister of Labour and Social Policy and the Minister of Health, promulgated, SGIssue 8 dated 30.01.2004, in force as of 31.01.2005, as amended, Issue 71 dated 1.09.2006, in force as of 2.12.2006, as amended and supplemented, Issue 67 dated 17.08.2007, Issue 2 dated 6.01.2012, Issue 46 dated 23.06.2015.
Article 1. (1) This ordinance determines:
1. the obligations of employers forprovision ofhealth and safety of workersworking with chemical agents;
2. the minimum requirements forprotection of workers fromexisting or potential risksto health and safetyupon exposure tochemical agents atwork;
3. limit values of chemical agentsin the air at the workplace specified in AppendixNo 1;
4. biological limit values ofchemical agentsand/or oftheir metabolitesinbiological media, as well as thebiomarkers of effect, as specified in Appendix No 2.
(2) The values ofchemical agentsin the air at the workplaceand the values ofchemical agentsandtheir metabolites inbiological mediamust not exceed thelimit values, as specified in Appendix No 1 and 2 .
(3) The values of thebiomarkers of effect must conform to thevalues specifiedin AppendixNo 2.
Article 2. (1) This ordinance is subject to application in allenterprises andlocationswhere labour activities are performedpursuant to Article 2 of the Health and Safety at Work Act, when the workers are or could beexposed tohazardouschemical agents at work.
(2) The protection of workers fromrisks involvingexposure tocarcinogens and mutagens, is subject to application of this Ordinance, in the event it envisionsmore stringent requirementsthan the requirements defined by theOrdinance onprotection of workers fromrisksinvolving exposure tocarcinogens and mutagensat work(SG, Issue 94 dated 2003).
(3) This Ordinance applies during thetransportation of chemical agents, when it envisions more stringentrequirements than the requirementsspecified by thespecial provisionsfortransportation of hazardouschemical agents.
Article 3. (1) The employermust adopt allmeasuresto determine thepresence ofhazardouschemical agents at theworkplace.
(2) In the event of presence of hazardous chemical agentsa risk assessment must be executed regarding thehealth and safety of workerspursuant toOrdinance No 5 dated 1999 on the order,manner, andrecurrence of risk assessment execution(SGIssue 47 dated 1999), taking the following into account:
1. hazardous properties ofchemical agents;
2. (As amended – SG, Issue 46 dated 2015) health and safety information, including thedata from thesafety data sheet, executed in line with the requirements ofAnnex ІІ toRegulation (EC) No 1907/2006 of the European Parliament and the CouncildatedDecember 18th, 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals(REACH), establishing a European Chemicals Agency, amending Directive No1999/45/ECand repealing Council Regulation (EEC) No 793/93 andCommission Regulation (EC) No 1488/94, as well as Council Directive 76/769/EECand Commission Directives 91/155/EEC, 93/67/EEC, 93/105/ECand 2000/21/EC (OJ L 396 dated 30.12.2006) (Regulation (EC) No 1907/2006), provided by the supplier of thesubstance or mixtureor by each participant in thesupply chain, required to perform risk assessment ofthe chemical substance or mixture;
3. the degree/level, type, andduration of exposure;
4. the conditions of work withhazardous chemical agents, as well as their quantities;
5. the limit values indicated inAppendix No 1 and 2;
6. the effect of the protective measures undertakenor subject to undertaking;
7. the conclusions of thehealth surveillancein cases with available data.
(3) The employer must assessthe conformity of adopted measuresto the requirementsofArticle 8, 9, 10,and 11.
(4) (As amended – SG, Issue 46 dated 2015) The producers/manufacturers, importers, andparticipants in thesupply chain forchemical agentsare obligated upon requestto provide theemployer:
1. complete information pursuant toArticle 3, Paragraph 2, Item 2 on hazardous chemical agentsrequired for execution of risk assessment ofworkers;
2. other available information requiredfor the specific risk assessmentof users, for the provision of whichobligations were not introduced inRegulation (EC) No 1907/2006andRegulation (EC) No 1272/2008 of the European Parliament and the Councilregarding theclassification, labeling, andpackaging ofsubstances and mixtures, for amendment and repeal ofDirectives 67/548/EECand 1999/45/ECand amendment ofRegulation (EC) No 1907/2006 (OJ L 353 dated 31.12.2008) (Regulation (EC) No 1272/2008).
Article 4. (1) The employer must documentthe risk assessmentpursuant to the requirements ofArticle 20 of Ordinance No 5 on the order, manner, andrecurrence for risk assessment execution. The assessment may containsubstantiation that thenature and scopeof risks connected tochemical agentsdo not requiremore detailed assessment.
(2) The health and safety risk assessmentmust be subjected to review pursuant to the provisions ofOrdinance No 5 on the order, manner, and recurrence forrisk assessment execution, as well as based upon the resultsof thehealth surveillance.
Article 5.During the risk assessmentthe repair activities, unplanned, but foreseeable events, the possibilities forarising ofindustrial accidents,and activities, which could lead by way of other reasons tounfavorable health and safety effects regardless of the adopted technical measures, must be taken into account.
Article 6. (1) During activitiesincluding exposureto severalhazardous chemical agents, their combined action must be subjected to assessment.
(2) During the simultaneous determination at the air of theworkplace of several hazardouschemical agentswith unidirectional action,the sum of relations of factual concentrations ofeach agent (c1, c2 ..... cn) in the air at the workplaceto therespective limit valueof the chemical agents(limit value 1, limit value 2 ..... limit value n) must not exceed 1:
С1 / С2 / Сn–––––– / + / –––––– / + / ..... + / –––––– / ? 1.
limit value 1 / limit value 2 / limit value
n
(3) During the simultaneousdetermination in the air of the workplace ofseveralhazardouschemical actionswithmultidirectional action,the limit values shall remainthe same as under their isolatedaction.
Article 7.The work includingcontact with hazardouschemical agentsshall commence after risk assessmentforhealth and safety of workersand adoption of all requisite protective measures.
Article 8.The employer must prevent or reduceto a minimum the risktohealth and safety of workersduring work withhazardous chemical agentsby implementing:
1. design andorganization ofsuitable work processes and workplaces;
2. supply andprovision ofsuitable equipment, protective equipmentand respective maintenance, ensuring health and safety during work;
3. limitation of number of workers, who are or could be exposed;
4. reduction to a minimum theduration andlevel of exposure;
5. adoption ofhygienic measures forprevention or reductionof possibility for exposure tohazardouschemical agents;
6. limitation of quantities of chemicalagentsto the minimumrequired for performance ofa specific type of work;
7. procedures for safe work, storage, and transportationofhazardous chemical agents, as well as waste, containing such agents.
Article 9. (1) In cases when risk assessment results indicaterisk to health and safety of workers, the employer must apply thespecific protection measurespursuant to Article 10, 11,and 12 and must provide health surveillance.
(2) ) In cases when risk assessment results indicatethat due t thequantity ofpresenthazardouschemical agents at the workplacethe risk to the health and safety of workersisinsignificantand adopted measures pursuant toArticle 8 are adequate forreduction ofsaid risk, the employermay not apply the measures pursuant toArticle 10, 11,and 12.
Article 10. (1) The employer is obligated toprevent orreduce to the possible minimumthe risk to health and safety of workersworking withhazardous chemical agentsby their replacement withchemical agents orprocesses, which are not hazardous orare less hazardous, when the nature of the performed workspermits these actions.
(2) When the nature of the workdoes not permitrisk elimination by way of replacement, the employer must applysafety and protection measures:
1. organization ofsuitablework processes and controlfacilities, as well as the use ofsuitable equipment and materials, in order to avoid or reduce to a minimumthe formation/emission ofhazardous chemical agents;
2. application of collectiveprotection measures at the sourceof the risk, such as effective ventilationand suitable organizational measures;
3. application ofindividual protective equipment, including persona protective equipment, when prevention of exposure to hazardous chemical agents is impossible in any other way.
(3) The measures pursuant to Paragraph 1 and 2 are supplemented bythe health surveillanceand are coordinated in line with thenature of the risk.
(4) The employer must performperiodic measurements of chemical agents, which may lead to risk for health and safety of workers at the workplace, and must compare these to thelimit valuesspecified in Appendix No 1, when:
1. assessment cannot be performed in any other way ofeffectiveness ofadoptedsafety and protection measures pursuant toParagraph 2;
2. change arises in conditions, which may lead to changes of theexposure.
(5) The employer must considerthe results of themeasurements pursuant to Paragraph 4 upon execution of its obligations forassessment ofhealth and safety risk to workers.
(6) In the event limit values are exceeded forchemical agents at the workplace,the employer mustimmediately undertakeprotective measures, taking into account the degree and nature ofexceeded limit values.
Article 11. (1) The employer is obligated toundertakerequisitetechnicaland/ororganizational measures(separation ofincompatiblechemical agents, suitable storage,etc.), in order to provide protectionto workersagainst the hazards, connected to thephysicochemical properties of thechemical agents, including to:
1. preventthe presence ofhazardous concentrationsofflammablesubstances andhazardous quantitiesofchemicallyunstablesubstances at theworkplace;
2. prevent the presence of sources of ignition, which may lead to fireand explosion, or disallow theformation ofunfavorable conditions, under which thechemically unstablesubstances or theirmixturescould give rise toharmfulphysical effects, when the nature of work does not permit performance of the provisions pursuant toItem 1;
3. reduce harmful effectsto health and safety of workersin the event of fireorexplosionofflammablesubstancesorharmful physical effects, caused bychemically unstablesubstances or theirmixtures.
(2) The work/operating equipmentand protection systems, provided on part of employer, must conform to the requirementscontained in thenormative deeds applicable to that equipment, connected to theconformity assessment. The technical and/ororganizational measures, adopted on part of employer, must be coordinated in line with therequirements of theOrdinance onessential requirements forconformity assessment offacilities andsystems forprotection, intended for use inpotentially explosiveatmosphere(SG, Issue 81 dated 2001).
(3) In the events of risk риск from formation ofpotentially explosive atmosphere, the employer must implement controlof the work equipmentand must provideprotection systems.
Article 12. (1) The employer must preparean action plan forprevention andliquidation ofbreakdowns, incidents, and accidents, connected tohazardous chemical agentsat theworkplace.
(2) The action plan must include,not less than once a year,emergency safety trainingand supply ofmeans/equipment and conditionsforfirst aid provision.
(3) In case of breakdowns, incidents, and accidentsinvolvinghazardous chemical agentsthe employer is obligated to:
1. immediately notify workers;
2. apply suitable measures forliquidation of consequences;
3. admit in the affected zone onlyworkersengaged in the performanceofrehabilitation andotherurgent works.
(4) The employer must provideworkers pursuant toItem 3 personal protective equipment, specializedprotective equipment, equipment and measuring devices, specified by typeandquantity in theemergency plan, used during theemergency situation.
(5) The presence ofunprotected persons in theaffected zone is disallowed.
(6) The employer must provide warning and other communication systemsrequired forsignaling of elevated risk to health and safetyfor undertaking actions pertaining toliquidation of consequences, provision of first aid, evacuation, andimmediaterescue operations, if required.
(7) The employer must provide information toofficials at the enterpriseand toexternal authoritiesandorganizations(emergency services, urgent medical aid, etc.), which shall contain:
1. established hazardsduring work, classification of hazards under priority order, envisioned protective measures andprocedures, based upon which theexternal authoritiesandorganizations shall developcorresponding measures andprocedures;
2. expected specificrisksduring the time ofbreakdowns, incidents, and accidentsinvolving hazardouschemical agents, includingprocedures fortheir prevention andliquidation.
Article 13.The employer must provideworkersand/or theirrepresentatives:
1. information regarding therisk assessment, along with additional datafor setting inmaterial changes at theworkplace, leading torisk assessment’s modification;
2. data regarding thehazardouschemical agentsduring work, risk to health and safety, respective limit valuesand otherlegal requirements;
3. training and informationregarding therespectiveprotective measures and actions, subject to undertaking for self-protection, as well as for protection ofremaining workers;
4. (As amended – SG, Issue 46 dated 2015) access to safety data sheetsofusedchemicalagents, provided on part ofsuppliersin line with the provisions of Article 31 of Regulation(EC) No 1907/2006;
5. reliability andupdates of information, which may be provided in different form,depending on thenature and level of risk–from verbal notificationtoindividual training, supported bywritten information.
Article 14.The employer is obligated to providemarkings ofcontainers andpipelines, indicating the type ofhazardouschemical agentsthey containalong with the respectivehazards.
Article 15. (1) The employer must disallowthe production and use ofchemical agentsspecified in Appendix No 3, as well as activitiesconnected to said agents.
(2) Exceptions are allowed pursuant toParagraph 1:
1. for scientific research purposes, testing and analyses;
2. for activities intended toeliminatechemical agentsobtained in the form ofbyproducts orwaste products;
3. for production of chemical agentspursuant to Paragraph 1, which are or are used asintermediate products.
(3) In cases pursuant toParagraph 2 theexposure of workers tochemical agentsmust be preventedvia the provision ofclosed production systemand their earliest possible use asintermediate chemical agents. The extraction ofchemical agentsfrom the closed systemshall be executed onlyfor process control orsystem maintenance.
(4) In cases pursuant to Paragraph 2 the employer is obligated toapprove aproject/design, containing:
1. arguments regarding theneed of useofrespectivechemical agents;
2. term of use;
3. annual quantity pertaining to the useofchemical agents;
4. modes of supply/deliveryand storage;
5. activitiesand/ortechnological processes andreactionsunder which the chemical agent shall be used;
6. number ofworkers involved in the operations;
7. health and safety provision measures.
(5) (As amended – SG, Issue 46 dated 2015) In cases specified pursuant toParagraph 2, the employers are obligatedto notifyDirectorate „Labour Inspectorate“ within a term of 30 daysprior to commencement of respective activityand must provideupon requeston part ofcontrol authoritiesthe approved project/designpursuant to Paragraph 4.
Article 16. (1) When the risk assessment results indicate risktohealth ofworkers, the employer must providehealth surveillancepursuant toOrdinance No 3 onmandatorypreliminary andrecurrentmedical examinations ofworkers(SG, Issue 16 dated 1987).
(2) (As amended - SG, Issue 2 dated 2012) The results of the health surveillanceand exposure levelsmust be recorded in thehealth files of workerspursuant to therequirements ofArticle 11, Paragraph 10 of Ordinance No 3 dated 2008 onconditions and order forimplementation of activities ofoccupational medicine services(SG, Issue 14 dated 2008).
(3) During the conduction of thehealth surveillancethe following must be taken into account:
1. possibility forexposure tohazardous chemical agent tocausespecificillness orhealth impairment;
2. probability forillness or health impairment toariseunder the specific labour conditionsof the worker.
(4) The detection ofillness or health impairmentresulting from theeffects ofchemical agentsshall be subject to the application oflow risk level examination methods, approved by themedical science and practice.
(5) The results of the health surveillancemust be taken into accountupon the planning andimplementation ofprotection measuresfor thespecific workplace.
Article 17. (1) In cases involving exposure to hazardous chemical agents, for which limit values are specified pursuant toAppendix No 2, the employer is obligatedto providethe conduction of examinationsunder the order provided for inOrdinance No 3 onmandatory recurrentexaminationsof workersfor determination ofbiomarkers of exposure and/orbiomarkers of effect.
(2) The employer must informworkers regarding theneed ofconduction ofexaminationspursuant to Paragraph 1 prior to commencement of work, connected to the risk ofexposure to thespecified hazardous chemical agent.
Article 18. (1) The health filesmust contain the results of theconductedhealthsurveillance and alldatapertaining to theexposure of the worker.
(2) Copies of respective filesmust be provided upon requestto theNational Social Security Institute.
(3) Each worker must be provided access to his/her health file.
(4) In the event of closing of the enterprisethe health file must be provided to theworker.
Article 19.In cases when the exposureof a specific workerleads to illnessor health impairmentorin the event of exceeded biological limit value, the physicianfrom theoccupational medicine service:
1. notifies the worker regarding the establishedillness orhealth impairment;
2. provides information and adviceregarding the health surveillanceconducted after the exposure has ended.
Article 20. (1) In cases pursuant toArticle 19 the employer:
1. reviews the risk assessment;
2. reviews and in the event of needundertakesadditional measurespursuant to the requirements ofArticle 8, 9, 10,and 11 for prevention orreduction of therisk;
3. conducts consultationswith occupational medicine specialists, other persons possessingsuitable qualifications, andcontrol authoritiesfor planning and conductionofmeasures, required forthe prevention or reductionof the risk pursuant to the provisions ofArticle 10 and 11, including regarding thepossibility forrelocation of the workerto another workplace, where no risk exists of further exposure;
4. organizes currenthealth surveillanceand provideshealth state inspectionto each other worker with similar exposure.
(2) In cases pursuant toItem 4 the physician from theoccupational medicine serviceproposes to theemployerto organize theconduction ofspecializedmedicalexamination.
ADDITIONAL REGULATION
§ 1.Within the meaning of this Ordinance:
1. "Chemical agent" shall mean eachchemicalsubstance and compound, independently or in a mixture, present in a natural stateor produced, used orexcreted, including in the form of wasteduringproduction activities, regardless of the fact whether it was produced or notand whether it wasintroduced on the market.
2. "Hazardous chemical agent" shall mean:
a) (As amended - SG, Issue 2 dated2012, Issue 46 dated 2015) each chemical agent, conforming to the classification criteriaashazardousaccording to the classes orphysical hazardsand/orhealth hazards, specified inRegulation(EC) No 1272/2008, regardless of the fact whether thechemical agent isclassified as hazardouspursuant to theoutlined regulation;
b) (As amended - SG, Issue 2 dated 2012, repealed, Issue 46 dated 2015);
c) (As amended - SG, Issue 46 dated 2015) each chemical agent, which without covering theclassification criteria as hazardouspursuant to letter „а“, due to itsphysicochemical, chemical, ortoxicologicalpropertiesand manner of use orpresence at theworkplace, may create risk to health and safety of workers, including eachchemical agent, for which a limit value wasspecified pursuant to the provisions ofAppendix No 1.
3. "Activity including chemical agents" shall mean each activityduring which chemical agents are used or could be usedin each process, including production, use, storage, transportation,ordisposal andrendering safe, or resultant from such activity.
4. "Limit value of specific chemical agentin the airat the workplace" shall mean the permissibleconcentration ofthe chemical agentin the airat the breathing zoneof the workerfor a specified period of time.
5. "Biological limit value" shall mean the permissible concentrationofrespectivechemicalagentor its metabolitein thebiological media, or reference valueofthe biomarker of effect.
6. "Health surveillance" shall mean the examination ofworkerfor health state assessmentin connection with theexposure tospecificchemical agentsduring work.
7. "Hazard" shall meanthe intrinsic propertyof a chemical agent, possible source of harm/injury.
8. "Risk" shall mean the probability ofsetting in of possible harm/injury during specific conditionsof useand/orexposure.
9. "Biomarker of exposure" shall mean the chemical agentor itsmetabolite/metabolites, established inbiological media (blood, urine, saliva, sweat, hair, nails,etc.).