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sustainability
Article
Defining Material Compliance—A Comprehensive Analysis
Lorena Buckreus 1, Anne-Kathrin Nuffer 2,*, Robert Miehe 2and Alexander Sauer 1,2
Citation: Buckreus, L.; Nuffer, A.-K.;
Miehe, R.; Sauer, A. Defining Material
Compliance—A Comprehensive
Analysis. Sustainability 2021,13,
13566. https://doi.org/10.3390/
su132413566
Academic Editors: Magnus
Wiktorsson, Monica Bellgran and
Seyoum Eshetu Birkie
Received: 29 October 2021
Accepted: 3 December 2021
Published: 8 December 2021
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Copyright: © 2021 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
4.0/).
1Institute for Energy Efficiency in Production (EEP), University of Stuttgart, 70569 Stuttgart, Germany;
lorena.buckreus@ipa-extern.fraunhofer.de (L.B.); alexander.sauer@ipa.fraunhofer.de (A.S.)
2Fraunhofer Institute for Manufacturing Engineering and Automation IPA, University of Stuttgart,
70569 Stuttgart, Germany; robert.miehe@ipa.fraunhofer.de
*Correspondence: anne-kathrin.nuffer@ipa.fraunhofer.de
Abstract:
The increase in the number of environmental regulations has resulted in great challenges
for corporations in the manufacturing industry, especially within the electronic and electrical and the
mechanical engineering sector. To address these compliance requirements, specialized management
fields such as environmental compliance, substructures and management approaches have been
implemented in industry. Recently, adherence to requirements concerning the composition of
products and the use of materials and substances within products has become increasingly important
and is referred to as material compliance (MC). Although the topic is of increasing importance, there
is no generally accepted definition for MC nor a management framework. Corporations are thus
unable to systematically address MC, and compliance violations occur frequently. We derived a
definition for MC based on extensive literature research, which we subsequently evaluated in a
quantitative survey. Our results indicate that MC is commonly understood as the adherence to
requirements concerning the composition of a product and the use of substances and materials within
products. By proposing a definition for MC, we aim to introduce a common understanding, enable
future research to systematically address the topic and develop a framework for the management
of MC.
Keywords:
material compliance; environmental compliance; product compliance; hazardous materi-
als management; hazardous substance management
1. Introduction
Ensuring compliance (the conformity of a corporation with rules, e.g., laws and
legislations [
1
–
3
]) is of increasing importance. This is mainly driven by the large amount,
growing number and stricter enforcement of legal and regulatory rules [
4
,
5
]. The rising
complexity makes it increasingly difficult for corporations to ensure their conformity with
the abundance of existing requirements [
3
]. Furthermore, violations can have considerable
adverse effects such as high monetary fines, loss of the operating license and other legal
claims, which might even result in existential threats for the respective corporation [
2
]. Due
to the increased awareness of the public and business partners, violations may further lead
to indirect costs caused by reputational damages [
2
,
4
]. Consequently, ensuring compliance
has become a crucial factor for corporate success [4,6].
As rules address increasingly specific topics, distinct compliance sub-types have
emerged, which are continuously diversifying. Compliance can thus be considered as an
umbrella term, which includes several sub-types of compliance such as environmental
compliance, product compliance, import compliance, etc., each addressing the conformity
with rules regarding a specific subject.
While ensuring overall compliance is crucial for each corporation, the composition
of relevant sub-types, which the respective corporations must consider to ensure over-
all compliance, might differ with regard to the respective corporate background and
industry sector.
Sustainability 2021,13, 13566. https://doi.org/10.3390/su132413566 https://www.mdpi.com/journal/sustainability
Sustainability 2021,13, 13566 2 of 12
In the manufacturing industry, the term Material Compliance (MC) has emerged and
is used to describe the adherence to requirements concerning a products composition and
the use of substances and materials within products. The VDMA, for example, which repre-
sents the interests of the mechanical engineering industry [
7
], uses the term to describe the
conformity with product requirements arising from the REACH (Registration, Evaluation,
Authorization and Restriction of Chemicals) regulation ((EC) No 1907/2006) and the RoHS
(Restriction of the use of certain Hazardous Substances) directive (2011/65/EU) [
8
]. While
MC is a relatively new topic in research [
9
], its practical importance for industry is increas-
ing rapidly. According to Müller [
9
], the number of product-related regulations concerning
chemical substances in products considerably increased between 2003 and 2019 (factor five)
and made up the largest part of the total amount of environmental regulations in 2019.
Figure 1demonstrates that corporations faced a continuous increase in the complexity of
the regulatory environment and the number of legislations and requirements concerning
the composition of products and the use of substances and materials within products and
other environmental requirements throughout the past years [10,11].
Sustainability2021,13,xFORPEERREVIEW2of13
Inthemanufacturingindustry,thetermMaterialCompliance(MC)hasemergedand
isusedtodescribetheadherencetorequirementsconcerningaproductscompositionand
theuseofsubstancesandmaterialswithinproducts.TheVDMA,forexample,whichrep‐
resentstheinterestsofthemechanicalengineeringindustry[7],usesthetermtodescribe
theconformitywithproductrequirementsarisingfromtheREACH(Registration,Evalu‐
ation,AuthorizationandRestrictionofChemicals)regulation((EC)No1907/2006)andthe
RoHS(RestrictionoftheuseofcertainHazardousSubstances)directive(2011/65/EU)[8].
WhileMCisarelativelynewtopicinresearch[9],itspracticalimportanceforindustryis
increasingrapidly.AccordingtoMüller[9],thenumberofproduct‐relatedregulations
concerningchemicalsubstancesinproductsconsiderablyincreasedbetween2003and
2019(factorfive)andmadeupthelargestpartofthetotalamountofenvironmentalreg‐
ulationsin2019.Figure1demonstratesthatcorporationsfacedacontinuousincreasein
thecomplexityoftheregulatoryenvironmentandthenumberoflegislationsandrequire‐
mentsconcerningthecompositionofproductsandtheuseofsubstancesandmaterials
withinproductsandotherenvironmentalrequirementsthroughoutthepastyears[10,11].
Figure1.Developmentoftheintroductionofregulationsandstandardsconcerningthecomposition
ofproductsandtheuseofmaterials/substanceswithinproductsandotherenvironmental
requirements(ownillustrationaccordingtodataretrievedfromtheComplance2Productplatform
(C2P)on11October2021)[12].
Asidefromthisevidentincrease,afurtheracceleratedintroductionofnewre‐
strictionscanbeexpected[13],e.g.,duetotheexpandingactivitiesoftherespectiveau‐
thoritiessuchastheEuropeanChemicalsAgency,whichisresponsibleforimplementing
theEuropeanUnion’schemicallegislation[14,15].
Geographicallyvaryinglegislationandrequirements,thecontinuousmodification
andadaptationoflegislation[11,16]anddivergingcustomerrequirements[9,17]further
complicatetheassuranceofcompliancewithproduct‐relatedrequirements.
Previousstudieshavealreadydemonstratedthattherisingrequirementsresultin
demandingtasksandchallengesforcorporationsinthemanufacturingindustry.Thelack
ofknowledgeaboutrelevantrequirementsandnecessaryinformation,e.g.,throughthe
lossofinformationthroughoutthesupplychainortheunavailabilityofinformationdue
toaninsufficientdatamanagement,posemajorchallenges[9,11,18,19].Fromamanage‐
mentperspective,theinsufficientdesignationofresponsibilitiesaswellasthelackofor‐
ganizationalortechnicalapproachestosystematicallyaddresstheassuranceofcompli‐
anceresultsindemandingtasksforcorporations[9,11,19].
0 1000 2000 3000 4000 5000 6000 7000 8000
2014
2015
2016
2017
2018
2019
2020
2021andpending
NumberofRegulationsandStandards
Time[Years]
Batteries ClimateChange Ecodesign ChemicalsinProducts
Figure 1.
Development of the introduction of regulations and standards concerning the composition
of products and the use of materials/substances within products and other environmental require-
ments (own illustration according to data retrieved from the Complance2Product platform (C2P) on
11 October 2021) [12].
Aside from this evident increase, a further accelerated introduction of new restrictions
can be expected [
13
], e.g., due to the expanding activities of the respective authorities such
as the European Chemicals Agency, which is responsible for implementing the European
Union’s chemical legislation [14,15].
Geographically varying legislation and requirements, the continuous modification
and adaptation of legislation [
11
,
16
] and diverging customer requirements [
9
,
17
] further
complicate the assurance of compliance with product-related requirements.
Previous studies have already demonstrated that the rising requirements result in
demanding tasks and challenges for corporations in the manufacturing industry. The lack
of knowledge about relevant requirements and necessary information, e.g., through the
loss of information throughout the supply chain or the unavailability of information due to
an insufficient data management, pose major challenges [
9
,
11
,
18
,
19
]. From a management
perspective, the insufficient designation of responsibilities as well as the lack of organi-
zational or technical approaches to systematically address the assurance of compliance
results in demanding tasks for corporations [9,11,19].
At the same time, the potential negative impacts of non-compliance on corporations
or responsible individuals are significant [
20
], including high fines, criminal charges, mar-
keting bans, loss of market access, revenues, and reputation [
9
,
20
], to name only a few.
Sustainability 2021,13, 13566 3 of 12
Nevertheless, the results of several studies show that violations within this field frequently
occur [
21
–
23
]. This demonstrates that, while the possible consequences of compliance
violations in this subfield are threatening, corporations struggle to meet the respective re-
quirements or deliberately accept the risks arising from marketing non-compliant products.
While the assurance of compliance with requirements concerning a products com-
position or the use of materials and substances within products is primarily a corporate
topic, its societal implications should not be underestimated. Supporting corporations in
their endeavors to ensure compliance with the requirements in this subfield contributes to
overall societal welfare. The reason is that the respective requirements often aim to protect
the environment or human health (e.g., (EC) No 1907/2006, article 1 REACH regulation
and 2011/65/EU, article 1 RoHS directive). Avoiding compliance violations is thus of
immediate importance to ensure economic, environmental and social welfare, e.g., by
avoiding hazardous substances that pollute the environment or threaten human health
or the extraction of resources that supports armed conflicts. Despite its importance for
industrial corporate practice, the number of publications and scientific literature findings
concerning MC are only marginal. There is no adequate management framework, nor has
a generally accepted definition for MC been established. Existing definitions primarily
represent the respective author’s subjective understanding of MC as they are commonly
not based on scientific considerations or the use of scientific methods. In contrast to this,
we aimed to elaborate a definition for MC with a high degree of objectivity by basing it on
the results of an explorative literature review and evaluating it using a quantitative survey.
As of now, the precise meaning and adequate operationalization of MC within corpo-
rations is unclear. This paper addresses this research gap and aims to provide a common
understanding of the term MC, thereby paving the way for the systematic development of
a comprehensive management framework.
2. Materials and Methods
Through the conduction of a literature review, we comprehensively analyzed the use
and the presented understanding of the term in literature. Relevant records were identified
following a search string according to the Preferred Reporting Items for Systematic Reviews
and Meta-Analysis (PRISMA) guidelines. Records were identified by searching for the
term “material compliance” and combinations of this term with “hazardous materials
management” “environmental management”, “environmental compliance”, “product
compliance” and “hazardous substance management”. All records addressing medicinal
topics or functional properties of materials were excluded as they were out of scope for this
research. Only sources which addressed the management of substances and/or materials
in industry and specifically used the term MC were included. Based on the findings of this
explorative analysis of literature, a definition was elaborated.
A quantitative survey further assessed the understanding of MC in industry and
whether there was some consensus about the meaning of MC. The accuracy of the elabo-
rated definition was evaluated directly by the participants of the survey during its conduc-
tion and further assessed by comparing the definition with the understanding of MC in
industry, which was analyzed through the survey. The results presented in this paper were
derived within the frame of a more extensive internal study addressing MC. The relevant
excerpts of the questionnaire are included in the Appendix Aof this paper.
We excluded sensitive information about the corporations such as their management
form and ownership structure and the respective parts of the questionnaire used to obtain
this information.
The data retrieved from the survey were then statistically analyzed and interpreted.
The research process of this study is illustrated in Figure 2.
Due to the large mechanical engineering and electrical and electronics sector in Ger-
many (approximately 2248 corporations [
24
]), the selection of a sample (n= 24) was neces-
sary [
25
]. The sample size was considered sufficient as professionals, working practically
within the field of MC, were selected as interviewees. Their opinions thus provide valuable
Sustainability 2021,13, 13566 4 of 12
insights into the practical understanding of MC. Concerning the scope and possibilities
of the study, it was determined that the intentional selection of elements that were to be
included in the survey was a functional approach, as we aimed to provide first insights
into a relatively unexplored research area [26].
Sustainability2021,13,xFORPEERREVIEW4of13
Thedataretrievedfromthesurveywerethenstatisticallyanalyzedandinterpreted.
TheresearchprocessofthisstudyisillustratedinFigure2.
Figure2.Demonstrationoftheresearchprocessofthisstudy(ownpresentation).
DuetothelargemechanicalengineeringandelectricalandelectronicssectorinGer‐
many(approximately2248corporations[24]),theselectionofasample(n=24)wasnec‐
essary[25].Thesamplesizewasconsideredsufficientasprofessionals,workingpracti‐
callywithinthefieldofMC,wereselectedasinterviewees.Theiropinionsthusprovide
valuableinsightsintothepracticalunderstandingofMC.Concerningthescopeandpos‐
sibilitiesofthestudy,itwasdeterminedthattheintentionalselectionofelementsthat
weretobeincludedinthesurveywasafunctionalapproach,asweaimedtoprovidefirst
insightsintoarelativelyunexploredresearcharea[26].
Toreceiveaccesstosuitableelementsofthetargetgroup,participantsoftheexpert
forum“GlobalEnvironmentalCompliance”,anindustryworkinggroupwhichaddresses
MCandisregularlyorganizedbytheFraunhoferInstituteforManufacturingEngineering
andAutomationIPA,wereaskedtoparticipateinthesurveyandrepresenttheirem‐
ployer(corporationsbelongingtothemechanicalengineeringorelectricalandelectronics
sector).Theparticipantsoftheexpertforumwereconsideredsuitablerepresentativesof
therespectivecorporations,astheyareprofessionallyinvolvedinthemanagementofMC
andarefamiliarwiththetopic.Itwasthusexpectedthattheycanprovidetherequired
informationandcompletethequestionnaire.Thequestionnairewasevaluatedandre‐
visedthroughtheconductionofapre‐test,priortotheactualsurvey.
Astandardizedsurvey[27]wasconductedbycombininganonlinequestionnaire
(createdwiththeCRM‐systemCASgenesisWorldX11(CASgenesisWorldX11,version
V21.1.6.11811,https://www.cas‐mittelstand.de,accessedon18June2021))withaphone
interview.Thiscombinationwasmeanttoensurehigherresponseratesbyincreasingthe
bindingcharacterofthesurvey[28].Simultaneously,thisallowedtheuseofcomplex
questionsascomprehensiveproblemscouldbesolveddirectlyduringtelephoneinter‐
views[29]andquestionscouldbesupportedvisuallyusingtheonlinequestionnaire[30].
TheinterviewswereconductedusingMicrosoftTeams(MicrosoftTeams,Version
1.4.00.11161,https://www.microsoft.com/de‐de/microsoft‐teams/download‐app,ac‐
cessedon18June2021)).Duringtheinterview,thecamerawasturnedoff,theinterviewer
openedtheonlinequestionnaireandsharedthedesktopwiththeparticipantsothatthe
participantcouldviewthequestionnaire.Thequestionswerethenreadtotheparticipants
bytheinterviewer,whonotedtheanswers.
Toacquireunbiasedanswers,theparticipants’understandingofMCwasassessed
first.TheparticipantswereaskedtostatewhatwasunderstoodunderthetermMCinthe
respectivecorporationintheirownwords.Theprovidedanswerswerequantifiedusing
aqualitativecontentanalysis,whichwasconductedusingtheprogramMAXQDAAna‐
lyticsPro2020Network.Categorieswereinductivelyderivedfromtheobtaineddata[31];
subsequently,theirfrequencywasdetermined,whichallowedforastatisticalanalysis
Figure 2. Demonstration of the research process of this study (own presentation).
To receive access to suitable elements of the target group, participants of the expert
forum “Global Environmental Compliance”, an industry working group which addresses
MC and is regularly organized by the Fraunhofer Institute for Manufacturing Engineering
and Automation IPA, were asked to participate in the survey and represent their employer
(corporations belonging to the mechanical engineering or electrical and electronics sector).
The participants of the expert forum were considered suitable representatives of the respec-
tive corporations, as they are professionally involved in the management of MC and are
familiar with the topic. It was thus expected that they can provide the required information
and complete the questionnaire. The questionnaire was evaluated and revised through the
conduction of a pre-test, prior to the actual survey.
A standardized survey [
27
] was conducted by combining an online questionnaire
(created with the CRM-system CAS genesisWorld X11 (CAS genesisWorld X11, version
V21.1.6.11811, https://www.cas-mittelstand.de, accessed on 18 June 2021)) with a phone
interview. This combination was meant to ensure higher response rates by increasing the
binding character of the survey [
28
]. Simultaneously, this allowed the use of complex ques-
tions as comprehensive problems could be solved directly during telephone interviews [
29
]
and questions could be supported visually using the online questionnaire [30].
The interviews were conducted using Microsoft Teams (Microsoft Teams, Version
1.4.00.11161, https://www.microsoft.com/de-de/microsoft-teams/download-app, ac-
cessed on 18 June 2021). During the interview, the camera was turned off, the interviewer
opened the online questionnaire and shared the desktop with the participant so that the
participant could view the questionnaire. The questions were then read to the participants
by the interviewer, who noted the answers.
To acquire unbiased answers, the participants’ understanding of MC was assessed
first. The participants were asked to state what was understood under the term MC in
the respective corporation in their own words. The provided answers were quantified
using a qualitative content analysis, which was conducted using the program MAXQDA
Analytics Pro 2020 Network. Categories were inductively derived from the obtained
data [
31
]; subsequently, their frequency was determined, which allowed for a statistical
analysis [
31
,
32
]. The participants were then asked to select regulations they consider
relevant for MC from a list. To avoid relevant regulations being overlooked, participants
could add regulations. To provide a manageable number of answer categories, only the
European legislation was explicitly named, while international legislation was included
Sustainability 2021,13, 13566 5 of 12
within the categories but not explicitly named. In the following item of the questionnaire,
the definition for MC derived from the previously conducted literature review (Section 3.1.)
was presented to the participants. The participants were then asked to evaluate whether
they thought that the definition was correct by providing an answer on a bipolar, numerical
rating scale with numerically labelled answer categories ranging from 1 (positive) to
6 (negative) and verbally labelled categories at both pole ends [
33
]. The obtained results
were statistically analyzed using Microsoft Excel.
3. Results and Discussion
3.1. Literature Review
Following a search string according to the PRISMA guidelines, relevant literature
sources were identified. This process is schematically illustrated in Figure 3.
Sustainability2021,13,xFORPEERREVIEW5of13
[31,32].Theparticipantswerethenaskedtoselectregulationstheyconsiderrelevantfor
MCfromalist.Toavoidrelevantregulationsbeingoverlooked,participantscouldadd
regulations.Toprovideamanageablenumberofanswercategories,onlytheEuropean
legislationwasexplicitlynamed,whileinternationallegislationwasincludedwithinthe
categoriesbutnotexplicitlynamed.Inthefollowingitemofthequestionnaire,thedefini‐
tionforMCderivedfromthepreviouslyconductedliteraturereview(Section3.1.)was
presentedtotheparticipants.Theparticipantswerethenaskedtoevaluatewhetherthey
thoughtthatthedefinitionwascorrectbyprovidinganansweronabipolar,numerical
ratingscalewithnumericallylabelledanswercategoriesrangingfrom1(positive)to6
(negative)andverballylabelledcategoriesatbothpoleends[33].Theobtainedresults
werestatisticallyanalyzedusingMicrosoftExcel.
3.ResultsandDiscussion
3.1.LiteratureReview
FollowingasearchstringaccordingtothePRISMAguidelines,relevantliterature
sourceswereidentified.ThisprocessisschematicallyillustratedinFigure3.
Figure3.Stringofsearchfortheselectionofrelevantliteraturesources(ownillustrationaccording
tothePRISMA2020guidelines[34]).
Intotal,sixsourceswereincludedinthereview.Throughtheanalysisandcompari‐
sonoftheapplicationofthetermMCinthesesources,whichisdescribedinthefollowing,
adefinitionwasderived.
Quevedo(1995)alreadyappliedthetermMCin1995inthecontextofadherenceto
regulationsconcerninghazardousmaterialsandwastestreams[35].Inamorerecentpub‐
lication,Phyperetal.(2004)definedMCas“[…]theactivitiesandprocessesusedtoen‐
sureanorganizationiscompliantwithlegislationrelatedtohazardous(regulated)goods
acrossallaspectsofbusiness[…]”[36].WhilePhyperetal.presentabroadscopeofMC
byincludingawiderangeoflegislationsandcorrespondingrequirements(e.g.,concern‐
ingtheregistration,notificationandlistingofchemicals,aswellastransportrequirements
[36])severalotherpublicationsrestrictthescopeofMCtotheconformityofproducts.
NieserandReusch(2017)relateMCtotheconformityofproductsbystatingthatit
isaproductcharacteristicthatneedstobeensuredtoavoidproductdeficiency.Theyfur‐
therdefineMCastheadherencetoallmaterialrelatedrequirements(e.g.,concerningthe
useofsubstancesormaterials)arisingfromlaws,norms,directivesandcustomerspecifi‐
cations,aswellasindustry‐specificregulations[17].MarkmannandNieser(2020)provide
Figure 3.
String of search for the selection of relevant literature sources (own illustration according
to the PRISMA 2020 guidelines [34]).
In total, six sources were included in the review. Through the analysis and comparison
of the application of the term MC in these sources, which is described in the following, a
definition was derived.
Quevedo (1995) already applied the term MC in 1995 in the context of adherence
to regulations concerning hazardous materials and waste streams [
35
]. In a more recent
publication, Phyper et al. (2004) defined MC as “[
. . .
] the activities and processes used to
ensure an organization is compliant with legislation related to hazardous (regulated) goods
across all aspects of business [
. . .
]” [
36
]. While Phyper et al. present a broad scope of MC
by including a wide range of legislations and corresponding requirements (e.g., concerning
the registration, notification and listing of chemicals, as well as transport requirements [
36
])
several other publications restrict the scope of MC to the conformity of products.
Nieser and Reusch (2017) relate MC to the conformity of products by stating that
it is a product characteristic that needs to be ensured to avoid product deficiency. They
further define MC as the adherence to all material related requirements (e.g., concerning
the use of substances or materials) arising from laws, norms, directives and customer
specifications, as well as industry-specific regulations [
17
]. Markmann and Nieser (2020)
provide a corresponding perspective and refer to MC as the conformity of products with
legally or contractually determined requirements regarding the material composition [
37
].
Other authors provide a similar perspective on MC: Takhar and Liyanage (2018)
apply the term to describe the adherence to regulations concerning the use of hazardous
chemical substances within products [
38
]. In accordance with this, Bachmann (2010) refers
Sustainability 2021,13, 13566 6 of 12
to MC as the conformity with requirements concerning the use of regulated substances
within products arising from national and international regulations, laws, and customer
requirements [
39
]. While some authors use the term substance when referring to chemicals
(e.g., [
38
]), the term material is not further specified by the respective authors. It is thus
unclear whether the terms need to be differentiated or if they are used redundantly.
Summarizing the previous findings, the term MC is predominately used to describe
the adherence to legal requirements concerning the composition of products [
17
,
37
] and
the use of materials and/or substances within products [
17
,
38
,
39
]. These requirements may
arise from legislation [
35
,
37
], customer requirements [
17
,
37
,
39
] or norms [
17
]. Norms are, in
general, not legally binding [
40
] unless their application is explicitly required by legislation.
With respect to these findings, we define MC as the conformity of products with all
relevant requirements regarding their composition, as well as the conformity of materials
and substances with all relevant requirements regarding their use within products.
According to this definition, MC includes the adherence to all legally binding as well as
other relevant requirements arising, for example, from laws, regulations, norms, directives,
industry-specific regulations and customer specifications. As corporations not only use
substances in the form of a specific chemical but rather a material (e.g., glue [
9
]), the
conformity of both materials and substances is included within the scope of MC according
to this definition.
3.2. Evaluation of the Elaborated Definition for Material Compliance and Analysis of the
Understanding of Material Compliance in the Mechanical Engineering and Electrical and
Electronics Industry
The provided answers concerning the participants understanding of MC were quan-
tified using a content analysis. Four categories were derived from the answer material
representing different aspects of the understanding of MC: adherence to legal require-
ments (legal) and adherence to requirements concerning products (product), substances
(substance) or materials (material). For several answers, more than one of these aspects
were assigned. The results illustrated in Figure 4show that the majority of participants
understood MC as adherence to legal requirements (66.67%) and requirements concern-
ing products (58.33%), while a large part further included adherence to requirements
concerning substances (33.33%) and materials (20.83%).
Sustainability2021,13,xFORPEERREVIEW6of13
acorrespondingperspectiveandrefertoMCastheconformityofproductswithlegally
orcontractuallydeterminedrequirementsregardingthematerialcomposition[37].
OtherauthorsprovideasimilarperspectiveonMC:TakharandLiyanage(2018)ap‐
plythetermtodescribetheadherencetoregulationsconcerningtheuseofhazardous
chemicalsubstanceswithinproducts[38].Inaccordancewiththis,Bachmann(2010)refers
toMCastheconformitywithrequirementsconcerningtheuseofregulatedsubstances
withinproductsarisingfromnationalandinternationalregulations,laws,andcustomer
requirements[39].Whilesomeauthorsusethetermsubstancewhenreferringtochemi‐
cals(e.g.,[38]),thetermmaterialisnotfurtherspecifiedbytherespectiveauthors.Itis
thusunclearwhetherthetermsneedtobedifferentiatedoriftheyareusedredundantly.
Summarizingthepreviousfindings,thetermMCispredominatelyusedtodescribe
theadherencetolegalrequirementsconcerningthecompositionofproducts[17,37]and
theuseofmaterialsand/orsubstanceswithinproducts[17,38,39].Theserequirements
mayarisefromlegislation[35,37],customerrequirements[17,37,39]ornorms[17].Norms
are,ingeneral,notlegallybinding[40]unlesstheirapplicationisexplicitlyrequiredby
legislation.
Withrespecttothesefindings,wedefineMCastheconformityofproductswithall
relevantrequirementsregardingtheircomposition,aswellastheconformityofmaterials
andsubstanceswithallrelevantrequirementsregardingtheirusewithinproducts.
Accordingtothisdefinition,MCincludestheadherencetoalllegallybindingaswell
asotherrelevantrequirementsarising,forexample,fromlaws,regulations,norms,direc‐
tives,industry‐specificregulationsandcustomerspecifications.Ascorporationsnotonly
usesubstancesintheformofaspecificchemicalbutratheramaterial(e.g.,glue[9]),the
conformityofbothmaterialsandsubstancesisincludedwithinthescopeofMCaccording
tothisdefinition.
3.2.EvaluationoftheElaboratedDefinitionforMaterialComplianceandAnalysisofthe
UnderstandingofMaterialComplianceintheMechanicalEngineeringandElectricaland
ElectronicsIndustry
TheprovidedanswersconcerningtheparticipantsunderstandingofMCwerequan‐
tifiedusingacontentanalysis.Fourcategorieswerederivedfromtheanswermaterial
representingdifferentaspectsoftheunderstandingofMC:adherencetolegalrequire‐
ments(legal)andadherencetorequirementsconcerningproducts(product),substances
(substance)ormaterials(material).Forseveralanswers,morethanoneoftheseaspects
wereassigned.TheresultsillustratedinFigure4showthatthemajorityofparticipants
understoodMCasadherencetolegalrequirements(66.67%)andrequirementsconcerning
products(58.33%),whilealargepartfurtherincludedadherencetorequirementsconcern‐
ingsubstances(33.33%)andmaterials(20.83%).
Figure4.Analysisoftheparticipantsunderstandingofmaterialcompliance.
SincetherewasaconsensusaboutthemostimportantaspectsofMC,theresultsin‐
dicatethatthereisatleastapartialcommonunderstandingforMC.Theresultsfurther
Figure 4. Analysis of the participants understanding of material compliance.
Since there was a consensus about the most important aspects of MC, the results
indicate that there is at least a partial common understanding for MC. The results further
correspond to the elaborated definition, which includes all the identified aspects, indicating
that the definition is accurate.
This is further supported by the rating results of the elaborated definition, which
participants rated on a scale from 1 (accurate) to 6 (not accurate). The results illustrated in
Figure 5show that the participants generally considered the elaborated definition accurate
as the values ranged between 1 and 4 (1 and 3 when excluding the outlier). Thus, none
of the participants rejected the definition entirely, and half of the participants provided a
Sustainability 2021,13, 13566 7 of 12
positive rating by selecting categories 1 or 2. On average, participants rated the definition
with 1.58 (mean). The standard deviation was 0.93, and the median was 1.
Sustainability2021,13,xFORPEERREVIEW7of13
correspondtotheelaborateddefinition,whichincludesalltheidentifiedaspects,indicat‐
ingthatthedefinitionisaccurate.
Thisisfurthersupportedbytheratingresultsoftheelaborateddefinition,which
participantsratedonascalefrom1(accurate)to6(notaccurate).Theresultsillustratedin
Figure5showthattheparticipantsgenerallyconsideredtheelaborateddefinitionaccu‐
rateasthevaluesrangedbetween1and4(1and3whenexcludingtheoutlier).Thus,none
oftheparticipantsrejectedthedefinitionentirely,andhalfoftheparticipantsprovideda
positiveratingbyselectingcategories1or2.Onaverage,participantsratedthedefinition
with1.58(mean).Thestandarddeviationwas0.93,andthemedianwas1.
Figure5.Ratingoftheaccuracyoftheelaborateddefinitionformaterialcompliance.
Participantswerefurtheraskedtoprovidereasonsiftheydidnotconsidertheelab‐
orateddefinitionaccurate.However,theprovidedanswerswerediverse,andcategories
orfrequenciescouldnotbedetermined.Thisdivergencemightresultfromthelackofan
officialdefinitionandadifferingunderstandingofMCdependingontherespectivecor‐
poratebackgroundandsituation.
ToprovidefurtherinsightsintotheunderstandingofMC,itwasanalyzedwhich
regulationsparticipantsconsideredrelevantforMC.TheresultsillustratedinFigure6
showthattheparticipantsconsideredalllistedregulationsasrelevant,primarilythe
RoHSdirective(2011/65/EU)andtheREACHregulation((EC)No1907/2006)(100%),fol‐
lowedbytheregulation(EU)2019/2021(PersistentOrganicPollutants(POP)regulation)
(91.67%),regulationsregardingconflictmineralsanddirective2012/19/EU(WasteElectri‐
calandElectronicEquipment(WEEE)directive)(79.17%).While54.17%ofthepartici‐
pantschosetoaddotherregulations,thisnumberiscompromisedbythefactthatseveral
participantsaddedregulationsthatwerealreadyincludedintheanswercategoriesas
similarinternationalregulations,orparticipantsaddedrequirementswhichcouldnotbe
consideredasregulations,e.g.,customer‐specificrequirements.Thus,only12.5%ofthe
participantsaddedregulationsnotpreviouslyincludedintheanswercategories.
Figure 5. Rating of the accuracy of the elaborated definition for material compliance.
Participants were further asked to provide reasons if they did not consider the elabo-
rated definition accurate. However, the provided answers were diverse, and categories
or frequencies could not be determined. This divergence might result from the lack of
an official definition and a differing understanding of MC depending on the respective
corporate background and situation.
To provide further insights into the understanding of MC, it was analyzed which
regulations participants considered relevant for MC. The results illustrated in Figure 6
show that the participants considered all listed regulations as relevant, primarily the RoHS
directive (2011/65/EU) and the REACH regulation ((EC) No 1907/2006) (100%), followed
by the regulation (EU) 2019/2021 (Persistent Organic Pollutants (POP) regulation) (91.67%),
regulations regarding conflict minerals and directive 2012/19/EU (Waste Electrical and
Electronic Equipment (WEEE) directive) (79.17%). While 54.17% of the participants chose
to add other regulations, this number is compromised by the fact that several participants
added regulations that were already included in the answer categories as similar inter-
national regulations, or participants added requirements which could not be considered
as regulations, e.g., customer-specific requirements. Thus, only 12.5% of the participants
added regulations not previously included in the answer categories.
Sustainability2021,13,xFORPEERREVIEW8of13
Figure6.Relevanceofdifferentregulationsformaterialcompliance.
Theseresultspartiallycorrespondtothepreviousfindingsandsupporttheassump‐
tionthattheelaborateddefinitionmightbeconsideredaccurateasthemostprominent
regulations(RoHSdirective,REACHandPOPregulation,regulationsconcerningconflict
mineralsandtheBatterydirective(2006/66/EC))regulatetheuseofsubstances/materials
inproducts(2011/65/EU,Article1;(EC)No1907/2006,Article1(2);(EU)2019/1021,Article
1,Article3;2006/66/EG,Article2(1),Article4)andarethereforeinlinewiththedefinition.
However,theresultsfurtherindicatethattheunderstandingofMCdiffers,sinceseveral
regulationsnotcorrespondingtotheelaborateddefinitionwereconsideredrelevantby
theparticipants(e.g.,theWEEEdirective,whichaddressesthegenerationandmanage‐
mentofwastefromelectricalandelectronicequipment(2012/19/EU,Article1)).Whilethis
indicatesthattherearedifferencesintheunderstandingofMC,itshouldalsobenoted
thatitcouldbeassumedthatregulationsthathavenotyetbeenassignedtoanothertopic
mightbeincludedwithinthetopicofMC.
4.Conclusions
Basedonanassessmentofexistingsourcesofliterature,wedefinedMCasthecon‐
formityofproductswithallrelevantrequirementsregardingtheircomposition,aswellas
theconformityofmaterialsandsubstanceswithallrelevantrequirementsregardingtheir
usewithinproducts.
ItisessentialtopointoutthatthisdefinitiondoesnotlimitMCtotheadherenceto
substance/materialrestrictionsorprohibitionsbutincludesallrequirementsregarding
theirusewithinproducts.Someexamplesareinformationrequirementsconcerningthe
useofasubstancearisingfromarticle33oftheREACHregulation((EC)No1907/2006,
Article33)andregulationsconcerningconflictmineralswhichdonotgenerallyprohibit
theuseofasubstancebutrequireresponsiblesourcing[41].Thisisinaccordancewiththe
presentedexemplaryunderstandingofMCinindustry,asaccordingtotheresultsofthe
survey,regulationswhichaddresssocialaspectssuchasthesourcingofconflictminerals
areconsideredrelevantforMC.
Theresultsofthequantitativesurveyfurtherdemonstratethattheparticipantsgen‐
erallyconsideredtheelaborateddefinitionasaccurate.Furthermore,theresultsindicate
someconsensusaboutthesignificantaspectsofMCandapartialcommonunderstanding
ofMC,butthereareindividualdifferences.Wheninterpretingtheseresults,itshouldalso
beconsideredthattheyonlyapplyfortheselectedsample.Thedemonstratedunderstand‐
ingappliestothemechanicalengineeringandelectricalandelectronicssectorandmight
differtotheunderstandinginotherindustrysectorssuchasthechemicalindustry,where
MCcouldbeconsideredastheconformitywithrequirementsconcerningsubstancesand
Figure 6. Relevance of different regulations for material compliance.
Sustainability 2021,13, 13566 8 of 12
These results partially correspond to the previous findings and support the assump-
tion that the elaborated definition might be considered accurate as the most prominent
regulations (RoHS directive, REACH and POP regulation, regulations concerning conflict
minerals and the Battery directive (2006/66/EC)) regulate the use of substances/materials
in products (2011/65/EU, Article 1; (EC) No 1907/2006, Article 1(2); (EU) 2019/1021,
Article 1, Article 3; 2006/66/EG, Article 2(1), Article 4) and are therefore in line with the
definition. However, the results further indicate that the understanding of MC differs,
since several regulations not corresponding to the elaborated definition were considered
relevant by the participants (e.g., the WEEE directive, which addresses the generation and
management of waste from electrical and electronic equipment (2012/19/EU, Article 1)).
While this indicates that there are differences in the understanding of MC, it should also be
noted that it could be assumed that regulations that have not yet been assigned to another
topic might be included within the topic of MC.
4. Conclusions
Based on an assessment of existing sources of literature, we defined MC as the confor-
mity of products with all relevant requirements regarding their composition, as well as the
conformity of materials and substances with all relevant requirements regarding their use
within products.
It is essential to point out that this definition does not limit MC to the adherence to
substance/material restrictions or prohibitions but includes all requirements regarding
their use within products. Some examples are information requirements concerning the
use of a substance arising from article 33 of the REACH regulation ((EC) No 1907/2006,
Article 33) and regulations concerning conflict minerals which do not generally prohibit
the use of a substance but require responsible sourcing [
41
]. This is in accordance with the
presented exemplary understanding of MC in industry, as according to the results of the
survey, regulations which address social aspects such as the sourcing of conflict minerals
are considered relevant for MC.
The results of the quantitative survey further demonstrate that the participants gen-
erally considered the elaborated definition as accurate. Furthermore, the results indicate
some consensus about the significant aspects of MC and a partial common understanding
of MC, but there are individual differences. When interpreting these results, it should also
be considered that they only apply for the selected sample. The demonstrated understand-
ing applies to the mechanical engineering and electrical and electronics sector and might
differ to the understanding in other industry sectors such as the chemical industry, where
MC could be considered as the conformity with requirements concerning substances and
not materials. Due to the participants’ regular attendance at the expert forum, a similar
understanding of MC might have been established within this sample. Nevertheless, as the
definition is based on existing literature and supported by the survey results, we assume
that it may provide a first approach towards defining MC.
The obtained results further demonstrate that MC cannot be equated with other
forms of compliance. Although there are intersections with other compliance types, MC is
considered as a distinct compliance sub-type. One might intuitively assign MC thematically
to product or environmental compliance. However, while MC concerns products, it cannot
be equated to product compliance, which is limited to the conformity of the finished
product and primarily focuses on the reduction of the product-specific risks for the product
user [
9
]. In contrast, MC includes the adherence to requirements concerning the use of
substances and materials within products and thus goes beyond the conformity of the
finished product by addressing the conformity of substances, materials, components, parts,
etc., that make up the finished product. It can neither be equated with environmental
compliance, which, according to Labinsky [
42
], can be understood as the conformity with
environmental regulations. Although relevant regulations address environmental aspects,
such as the REACH regulation ((EC) No 1907/2006), Article 1), MC goes beyond this, as
demonstrated by the results discussed in Section 3.2, as MC additionally includes social
Sustainability 2021,13, 13566 9 of 12
aspects, e.g., the responsible sourcing of conflict minerals [
43
]; Public law No. 111–203,
Section 1502 [
44
].Thus, MC must be considered as a distinct form of compliance and as a
part and requirement for the overall compliance of a corporation.
In this study, we derived and evaluated a definition for MC to provide the necessary
conditions to address the topic in research and corporate practice systematically. As
corporations face a complex regulatory environment, developing a management framework
to ensure MC remains an essential task for future research.
While this study provides the first insights into this relatively new topic, the applied
method of sample selection, its composition and size should be considered when interpret-
ing the results. Due to the non-random selection of participants, the results can statistically
not be generalized [
45
]. Nevertheless, this method was considered applicable as the par-
ticipating corporations are expected to address MC proactively and might function as
trendsetters for the rest of the industry. Furthermore, the participants of the survey are
professionals within the field of MC and can provide valuable insights as the management
of MC is part of their everyday business. Their opinions and judgement are thus regarded
as highly relevant.
Considering these limitations, we do not claim representativeness of the results.
Instead, this study aims to provide a first systematic insight and to generate a reference
point for future research.
5. Summary and Outlook
In this study, we aimed to analyze the understanding of MC in industry, as well as
the literature, and develop a definition for the term MC with a high degree of objectivity.
Therefore, we conducted an explorative literature review and compared the use and
application of the term MC in literature. Based on the results of this literature review, we
derived a definition for MC. In a quantitative survey, we analyzed the understanding of
MC in industry, determined whether there was a consensus and identified the aspects
considered relevant for MC.
We compared the analyzed understanding of MC to the previously elaborated defini-
tion and discussed whether the definition matched this understanding. Additionally, we
evaluated the definition directly during the conduction of the survey by asking participants
to rate the accuracy of the definition.
The results demonstrate that, although there is no generally accepted definition for
the term MC, there is some consensus about the relevant aspects and regulations, which
need to be considered to ensure MC. It was further demonstrated that the elaborated
definition matched this understanding of MC and was generally considered as accurate by
the participants.
Through the elaboration and evaluation of a definition for MC, we aim to facilitate
communication and knowledge exchange and provide the necessary conditions to address
the topic in research and corporate practice systematically. Thereby enabling further
progress in the management of MC.
Previous research in this field has so far focused on the management of data and
information and the design of processes and structures required to ensure MC. It should
be noted that some of the relevant publications do not use the term MC, as it has not yet
become established in scientific literature.
The adequate management of data and information necessary to ensure MC has
been the subject of several publications (e.g., [
16
,
39
,
46
]). Although there is a consensus
about the fact that a standardized and uniform system for data exchange is required to
ensure MC [
39
,
46
], the authors of the respective publications recommend several software
solutions (e.g., [
16
,
39
]. It thus remains a task for future research to develop an adequate
and standardized solution for the management of data and information to ensure MC.
The processes required to ensure MC have been discussed in several publications with
varying degrees of detail (e.g., [
9
,
11
,
17
,
20
,
37
]. While Müller has developed a reference
model describing the actions necessary to ensure MC [
9
] there is currently no standardized
Sustainability 2021,13, 13566 10 of 12
process, nor has the practical applicability of the discussed processes been tested. Although
the management of data and information as well as processes require the establishment
of adequate corporate structures, this has only marginally been addressed in literature
(e.g., in [17,47]).
The identification of the required corporate structures therefore remains
an additional task for future research.
As of now, existing studies have not provided a holistic approach for the management
of MC but focus on several aspects separately. A systematic approach would require an
integration of the management of data and information, required processes and structures.
Developing such a management framework to ensure MC thus remains another essential
objective for future research.
Author Contributions:
Conceptualization, L.B.; methodology, L.B. and A.-K.N.; formal analysis,
L.B. and A.-K.N.; investigation, L.B. and A.-K.N.; resources, R.M. and A.S.; writing—original draft
preparation, L.B.; writing—review and editing, L.B., A.-K.N. and R.M.; visualization, L.B.; supervi-
sion, R.M., A.-K.N. and A.S.; project administration, L.B. All authors have read and agreed to the
published version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: Not applicable.
Informed Consent Statement:
Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: Data sharing is not applicable to this article.
Conflicts of Interest: The authors declare no conflict of interest.
Appendix A
Question 14: Please state in one to two sentences what’s understood under the term
Material Compliance in your corporation.
___________________________________________________________________
Question 15: Which of the following regulations would you assign to the topic of Mate-
rial Compliance? Instruction: multiple answer categories can be selected. Please name
other relevant regulations in the provided space if they are not included in the list of
answer categories.
REACH regulation ((EC) No. 1907/2006) and similar international regulations
RoHS directive (2011/65/EU) and similar international regulations
WEEE directive (2012/19/EU) and similar international regulations
Regulations regarding conflict minerals (e.g., Section 1502 des Dodd-Frank Acts or
the European conflict minerals regulation ((EU) 2017/821)) and similar
international regulations
POP (persistent organic pollutants) Regulation ((EU) 2019/1021) and similar
international regulations
ErP directive (2009/125/EC) and similar international regulations
Packaging and packaging waste directive (94/62/EC) and similar
internationa regulations
Battery directive 2006/66/EC and similar international regulations
Safety relevant regulations (e.g., regulations requiring the CE marking such as ma-
chinery directive (2006/42/EC)) and similar international regulations
Other: _________________________________________________________
Question 16: Do you consider the provided definition as accurate? “Material Compli-
ance is defined as the conformity of materials, substances and products with all relevant
requirements regarding their use, composition and constitution”.
(accurate) (1) ——- (2) ——- (3) ——- (4) ——- (5) ——- (6) (not accurate)
Sustainability 2021,13, 13566 11 of 12
Please provide reasons for your decisions (e.g., missing aspects):
______________________________________________________________________________
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