2008 Annual Report

Superior Health Council

2008 Annual Report Superior Health Council

Address: 4, rue de l’Autonomie B-1070 Brussels.

Tel: +32 2 525 09 00 Fax: +32 2 525 09 77

E-mail: info.hgr-css@health.fgov.be Website: www.health.fgov.be/CSS_HGR

Legal deposit no.: D/2009/7795/7 ISBN no.: 9789076994789

Public notices as well as brochures may be consulted in full on the Superior Health Council website. The printed version of the brochures is available upon request by addressing a written application by post, fax or e-mail to the aforementioned address.

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Annual report 2008

1 . PREFACE ...

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2 . INTRODUCTION ...

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3 . LEGAL PROVISIONS AND MISSIONS ...

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LEGAL PROVISIONS ... 7

MISSIONS ... 8

4 . RESTRUCTURING ...

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EXPERTS AND MEMBERS ... 9

QUALITY ... 9

COMMUNICATION ... 10

COLLABORATION ...1 1 AUDIT ... 12

HISTORY ... 13

5 . PRESENTATION OF THE FIELDS AND PRINCIPAL RECOMMENDATIONS ISSUED IN 2008 ...

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5.1. MENTAL HEALTH ... 14

Prescription of psychotropic medicines for stress, anxiety, sleeping disorders and depression (SHC 8155) ...14

Behavioural disorders in children and adolescents (SHC 8295) ...15

5.2. PHYSICAL ENVIRONMENTAL FACTORS ... 16

Recommendation by the SHC with regard to the draft RD on import, export, transit and distribution of radioactive substances (SHC 8399) ...17

Recommendations relative to the draft Royal Decree modifying the Royal Decree of 20 July 2001 on the general regulations for the protection of the population, workers and the environment against the danger of ionising radiation (SHC 8427) ...18

Recommendation relative to measures to be taken in the agricultural sector after potential contamination of the food chain by radioactive substances (SHC 8321) ...19

Recommendation of the Superior Health Council on the issue of cremation of bodies carrying radioactive sources (SHC 8416) ...19

Table of Contents

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Annual report 2008

Exposure of the population to magnetic fields from electric facilities

(SHC 8081) ... 2 1

Potential biological effects of modulated microwaves (SHC 8194) ... 22

Overview of advisory reports 2000-2008 (SHC 8433) ... 22

Health impact of high-frequency sounds produced by the Mosquito device (SHC 8415) ... 22

5.3. CHEMICAL AGENTS ...24

Toxic chemicals in children’s pyjamas (SHC 8424)... 25

5.4. DIET, NUTRITION AND HEALTH, INCLUDING FOOD SAFETY (NASSA) ...26

Nutritional recommendations for Belgium – revised (SHC 8309) ... 28

Safety of oils and fats – quality criteria and toxicological aspects (SHC 8310) . 28 Evaluation of the exposure to risks linked to the natural presence of certain contaminants in natural mineral waters (SHC 8311) ... 29

Exclusive sale in pharmacies of infant formulas (SHC 8434) ... 29

5.5. “BLOOD AND BLOOD PRODUCTS” AND “CELLS, TISSUES AND ORGANS OF HUMAN AND ANIMAL ORIGIN” ... 32

Expert meeting “Guidelines for the use of immunoglobulins” (SHC 8366) ...33

Aphaeresis techniques for the removal of erythrocytes (SHC 8405) ...34

Anti-HBc screening during collections following the initial blood donation (SHC 8352) 35 The reduction of pathogens in platelet concentrates (SHC 8390) ... 35

Inactivation and safety of tissues, cells and organs with respect to bacteria, viruses and prions (SHC 8143) ... 37

Quality standards for human tissues and cells intended for human applications . 37 Recommendations on the selection of donors for the attention of the managers of tissue and cell banks and for transplantation coordinators (SHC 8343) ... 38

Recommendation by the SHC on brain autopsy for the transcranial removal of the ossicles from the inner ear and technique to be used to search for (v)CJD during said autopsy (SHC 8340) ... 39

5.6. VACCINATION, INFECTIOLOGY AND CONTROL OVER INFECTIOUS DISEASES ...40

Vaccination sheet: Human papillomavirus (SHC 8460) & vaccination sheet: Whooping cough (SHC 8369) ... 4 1 2008 vaccine schedule (SHC 8398) ... 4 1 Recommendations with respect to the control over infections during care administered outside of healthcare establishments (at home and/or within a medical or paramedical office) (SHC 8279) ...43

Belgian recommendations for the control and prevention of Clostridium difficile infections in acute hospitals and in nursing and care homes (SHC 8365)...44

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5.7. MISCELLANEOUS ...45 The issue of Leptospira interrogans in Belgium (SHC 8334) ... 45 Oxygen bars (SHC 8410) ... 46 Treatment for “Chronic Fatigue Syndrome” (CFS): joint advisory report of

the Superior Health Council and the Federal Centre for Healthcare Expertise (SHC 8338) ...47

6 . SOME STATISTICS ...

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7 . SUPERIOR HEALTH COUNCIL STRUCTURE ...

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Annual report 2008

This.annual.report.of.the.Superior.Health.Council.(SHC).will.provide.you.with.an.overview.

of.activities.carried.out.in.2008.

The.diversity.of.topics.broached.is.impressive.and.indicates.the.complexity.of.the.study.

of.the.impact.of.environmental.factors.on.public.health.

Thankfully,.the.SHC.experienced.no.crisis.situation.in.2008,.which.allowed.it.to.bring..

the.reforms,.which.had.been.ongoing.for.several.years,.to.a.successful.conclusion..200.

experts.have.been.appointed,.among.whom.40.have.been.designated.as.members.of.the.

Board, which will provide the Council with a new official structure in early 2009 – the year of.its.160th.anniversary.

The. annual. report. allows. to. account. for. the. topics. broached,. but. not. the. procedures..

implemented.to.issue.advisory.reports..It.is.precisely.this.aspect.that.has.been.the.subject..

of.considerable.efforts.in.the.past.few.years..The.SHC.highly.values.its.independence.and.

the scientific argumentation of its opinions. Therefore special attention must be paid . to.transparency.in.the.context.of.contemporary.society..It.concerns.a.broader.phenomenon..

with.which.advisory.bodies.in.other.countries.are.also.faced..The.network.(EuSANH:.European..

Science. Advisory. Network. for. Health),. which. the. SHC. has. developed. in. collaboration.

with the Dutch National Health Council, should allow us to benefit from the experience of others.and.to.familiarise.them.with.our.working.methods.

All. this. implies. giving. further. thought. to. the. advice. formulation. process.. To. this. end,.

procedures must be elaborated, tested and implemented. This stage is more difficult and requires.an.effort.on.the.part.of.everyone.involved.in.the.advice.formulation,.but.it.will.

bear.fruit.over.time.

The.Committee.insists.on.thanking.all.those.who.have.contributed.to.the.successful.operation..

of.the.SHC.in.2008..It.is.convinced.that.the.future.looks.promising.thanks.to.the.new.

organisation, which will guarantee efficient operations. Our achievements in the methods used.to.accomplish.them.will.undoubtedly.prove.to.be.highly.satisfactory.for.SHC.members,..

as well as for administrative and scientific staff and the Council’s stakeholders.

On behalf of the Committee,

5

1 . PREFACE

G. De Backer, Chairman

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2008. was. a. very. special. year. for. the. Superior. Health. Council:. on. the. one. hand,. reforms..

initiated.in.2006.were,.for.the.most.part,.materialised.with.respect.to.legislation.(as.was.the.

case.quite.recently.for.the.new.Board);.on.the.other.hand,.the.Council.wanted.to.celebrate..

its. 160th. anniversary. by. emphasising. its. numerous. hours. of. glory,. as. well. as. its. role. of.

fundamental scientific support to politicians in the area of public health in Belgium. Even if the.latter.has.evolved.over.time.and.with.the.changes.that.have.taken.place.in.society,.it.

nonetheless.is.still.current.today..

In.short,.this.memory.work¹ pays tribute to all those who have – for the most part on a voluntary . basis – dedicated their time in order to contribute to the improvement of public health in.

our.country.

Lastly, contemporary society has undergone a major development since 1849 and the Council is.preparing.to.face.the.new.challenges.of.the.third.millennium.

This.annual.report.aims.to.provide.a.summary.of.these.various.aspects,.as.well.as.of.all.the.

activities.carried.out.within.the.Superior.Health.Council.over.the.past.year.

It obviously does not depart from the habit to present the efforts in the Council’s various areas of activity. For each area, scientific staff has suggested an executive summary of the principal.opinions.given..All.of.the.practical.information.relative.notably.to.the.composition.

of.the.Council.is.included.in.the.last.section.

This.annual.report.will.be.available.in.its.printed.version.as.well.as.on.the.Superior.Health.

Council’s website. If the entire advisory text is available for consultation on the website, you will find a link to it in the title of the executive summary.

2 . INTRODUCTION

1 A history book – the result of research carried out by Elisabeth Bruyneel on available sources – will be presented during the General Assembly of 15 May 2009 (it will be published in Dutch and French and will be distributed in collaboration with Peeters Publishing).

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The Superior Health Council is a federal scientific advisory body, which deals with numerous matters.involving.public.health..The.Superior.Health.Council.is.part.of.the.Federal.Public.

Service,.Health,.Food.Chain.Safety.and.Environment..It.represents.a.link.between.politics.

and the scientific world in the area of public health. The Council provides advice and recom- mendations on its own initiative or at the specific request of the ministers involved or the administration.

Legal provisions

The Superior Council of Hygiene was created by the Royal Decree (RD) of 15 May 1849 . instituting.a.Superior.Council.of.Public.Hygiene..It.was.reorganised.by.the.RD.of.14.September..

1919 (Belgian State Gazette of 01/10/1919), the RD of 4 December 1990 (Belgian State Gazette of 24/01/1991), the RD of 20 June 1994 (Belgian State Gazette of 26/07/1994), the RD of 11 April 1995 (Belgian State Gazette of 20/05/1995), the RD of 31 May 1996 (Belgian State Gazette of 08/10/1996) and the RD of 19 April 1999 (Belgian State Gazette of 03/06/1999).

In 2007 these decrees were replaced by a new Royal Decree of 5 March 2007 (Belgian State Gazette of 21/03/2007) leading to the creation of the Superior Health Council. This decree provides an overview of the SHC’s missions and its composition and governs the operations of its management bodies. “Chapter VI – Superior Health Council” has, in addition, been introduced into the programme law of 27 April 2007 (Belgian State Gazette of 8 May 2007) making the creation of the SHC official in the law. The Royal Decrees, for which the advice of the.SHC.is.requested,.therefore.have.a.legal.foundation.without.an.explicit.legal.obligation..

being.necessary..

Other legal provisions and regulations task the Superior Health Council with issuing advisory . reports in a number of specific areas. For example, in accordance with the provisions of the health law of 1 September 1945, the Superior Health Council’s advice is required for any measures.taken.in.the.area.of.public.health.in.general.

3 . LEGAL PROVISIONS AND MISSIONS

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Missions

A detailed overview of all the Superior Health Council’s legal missions in compliance with the aforementioned.Royal.Decrees.and.numerous.other.laws.and.regulations.is.available.on.the.

Superior Health Council’s website.

In.addition,.the.SHC.also.acts.on.its.own.initiative.

Two major mission categories can be distinguished among the Council’s activities:

. •.The.study.of.subjects.falling.under.all.areas.of.public.health.

. •. The.evaluation.of.specific.dossiers,.typically.introduced.as.part.of.an.approval.or..

authorisation of products or preparations for which the Superior Health Council’s . advice is required within a specific deadline. This concerns more particularly human . . . therapeutic.substances,.tissue.banks,.foodstuffs,.water,.packaging.materials,.pesticides,..

. . biocides,.dangerous.substances.

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Experts and members

As.we.have.stated.in.previous.annual.reports,.the.restructuring.of.the.Council.takes.time..

After the “new” creation of the Council in 2007 by RD (05/03/2007, Belgian State Gazette of . 21/03/2007) and by law (programme law of 27/04/2007, Belgian State Gazette of 08/05/2007) . and the approval of the internal regulations (08/05/2007, Belgian State Gazette of 21/06/2007),.

a new milestone was set in 2008: the appointment of 200 experts as the Council’s experts.

The.Ministerial.Decree.of.21.March.2008.on.the.appointment.of.experts.within.the.Superior.

Health Council selected 193 experts whose expertise corresponds to the various areas of activity.of.the.Council..

Among.them,.40.members.were.designated.to.form.the.Board;.the.RD.was.signed.by..

the King in early 2009. Within this group only the chairman and two vice chairmen still . remain to be elected. These procedures should be completed by 15 May 2009 – date of the Council’s 160th anniversary – and they will give the Council a new shot in the arm in the context.of.this.new.structure.

Quality

As regards the quality approach, whilst 2007 was primarily devoted to the ratification of . numerous.descriptive.working.method.procedures,.2008.was.marked.by.the.progress.made.

by several quality endeavours relative to more practical concerns for the Council’s experts..

For. example,. in. a. very. operational. way,. the. procedure. relative. to. the. relationship. SHC..

experts.are.bound.to.have.with.the.press.was.translated.into.a.concise.memorandum.

An.internal.reports.review.committee.was.set.up.and.is.in.its.testing.stage.in.agreement.with.the.Board...

This.committee.convenes.before.the.advisory.reports.are.validated.by.the.Board.and.is.made..

up.of.staff.members.external.to.the.working.groups..It.primarily.endeavours.to.correct..

the.form.of.the.report,.its.readability,.clarity.and.lack.of.ambiguity.of.the.objective.and.

conclusions.in.order.to.improve.the.impact.of.the.advisory.reports.on.the.political.world...

The committee’s remarks are submitted for the approval of the experts in the working group. . In.order.to.obtain.feedback.on.our.reports,.the.initial.surveys.relative.to.the.satisfaction..

of.the.administration.and.the.Cabinet.were.conducted.at.the.end.of.the.year..A.few.months.

from.now,.further.surveys.will.be.held.among.experts.associated.with.SHC.activities.

4 . RESTRUCTURING

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Another.key.aspect.held.all.our.attention:.the.SHC.has.decided.to.carry.out.an.in-depth.review..

of the management of conflicts of interests among experts sitting on the Council. This highly . ambitious project was launched in mid-2008 and will continue in 2009. In order to take.

into.account.the.sensitivities.of.the.various.areas,.experts.from.different.groups.have.been..

associated.with.the.project.

Within the scientific world, decisions increasingly rely on proof. Evidence-Based Medicine . or.EBM.becomes.the.reference..The.strength.of.the.SHC.obviously.lies.in.the.speed.with.

which it responds to requests, even in cases where scientific literature is quite limited. In any case, the SHC would like its recommendations – a few projects initially – to be increasingly based on EBM-oriented criteria. To this end, in September scientific secretaries have followed . a. training. session. organised. by. the. CEBAM. (Centre. for. Evidence-Based. Medicine). on. this.

approach.and.will.therefore.be.our.guides.as.we.change.course.

Lastly,.the.deliberation.project.involving.the.roadmap.containing.performance.and.quality.

indicators. is. making. good. progress.. The. implementation. of. the. initial. measures. will. take.

place in early 2009.

Prospects for 2009

The.various.projects.launched.in.2008,.such.as.the.conflict.of.interest.management,.

the definition of quality criteria for our advisory reports and the introduction of indicators . are continuing in their own sweet way. After many months of reflection, it is time to materialise . ideas,.to.implement.them.and.to.carry.out.the.initial.analyses.

Communication

In.2008,.the.Council.pursued.its.efforts.aimed.at.getting.better.known.among.professionals..

directly affected by its opinions and – generally – at being recognised as a source of expertise . in the health field. A number of opinions provided in 2008 have for that matter had a much broader.scope.and.have.been.the.subject.of.special.attention.in.the.media.(biological.effects.

of.modulated.microwave.radiation,.vaccination.against.whooping.cough,.vaccination.against.

seasonal influenza, mosquito, oxygen bars, etc.).

In.addition,.2008.marked.the.development.of.internal.communication.tools.(standardised.

internal.procedures.notably.for.relations.with.the.media.and.creation.of.a.newsletter.for.SHC.

experts) and the preparation of a history book published on the occasion of the Council’s 160th.anniversary.

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Internal. communication. particularly. concerns. the. 200. new. experts. named. by. Ministerial..

Decree of 16/04/2008, as well as the freshly appointed Board. With the Council’s reform . nearly completed, it was critical to have efficient tools available for the exchange of information . between.experts.with.different.backgrounds.or.simply.for.the.practical.organisation.of..

their.activities.

These.various.tools.could.for.that.matter.prove.to.be.quite.useful.for.the.exchange.of..

information.on.an.even.broader.scale,.i.e.,.the.EuSANH.(European.Science.Advisory.Network.

for.Health).project..In.this.respect,.the.SINAPSE.platform.should.enable.the.Council.to..

step.into.the.21st.century.and.to.implement.modern.communication.procedures.(NTIC:.New..

communication.and.information.technologies),.in.particular.virtual.spaces.(e-communities).

allowing for the common issue of scientifically founded opinions at European level.

Some 30 opinions by the Council have been the subject of a web publication in 2008. . The. large. majority. involved. health. professionals. (e.g.. radioprotection,. review. of. quality.

standards.for.cells.and.tissues,.leptospirosis,.reduction.of.pathogens.in.platelet.concentrates,..

sale in pharmacies of infants formulas, etc.). Others, as we have already stated, led to a broader.debate.(notably.the.review.of.the.HPV.immunisation.record).even.to.speculation..

– unfounded for the most part – on a recommendation in the pipeline (behavioural disorders . in.children.and.adolescents).

During the summer, report n° 8365 “Belgian recommendations for the management . and.prevention.of.Clostridium difficile.infections.in.acute.hospitals.and.in.nursing.and.care.

homes” was published in the form of a brochure and was the subject of a major information . campaign targeted at the relevant health professionals. Three further brochures were finalised . and will be widely disseminated in early 2009: they comprise “Recommendations on hand hygiene” (hospital and healthcare personnel), “Recommendations on infection management . during care given outside of care facilities” (general practitioners) and the review of “Nutritional . recommendations” (dieticians).

Collaboration

Internationally

The Council’s activities also extended to the international level:

. • Scientific recommendations play an increasingly important role in supporting political . . . decisions,.both.nationally.and.internationally..However,.international.collaboration..

. . between.advisory.bodies.is.rather.limited..That.is.why.the.EuSANH.(European.Science..

. . Advisory.Network.for.Health).network.was.created,.a.joint.initiative.by.the.Dutch..

. . Health.Council.and.the.SHC..The.aim.is.to.reduce.the.overlapping.of.activities,..

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. . to.make.the.best.use.of.available.and.often.limited.expertise.as.well.as.to.achieve..

. . an. optimal. methodology. with. respect. to. the. issue. of. recommendations. based. on..

scientific evidence. In 2008, after a number of preparatory meetings in previous . . . years,.a.project.was.submitted.to.the.European.Commission,.under.the.leadership..

. . of.the.Dutch.Health.Council.in.view.of.implementing.a.permanent.European.structure..

. . for. the. issue. of. health. recommendations.. The. Commission. approved. this. proposal..

and over the period 2009-2011, health advisory bodies from six countries, among . . . which.Belgium,.will.collaborate.on.this.project..In.this.context,.the.Council.took.part..

in the third EuSANH meeting on 4 and 5 December 2008. Some dozen health councils . . . from. EU. Member. States,. as. well. as. delegates. from. various. European. Commission..

Directorates and other international scientific organisations met in The Hague in order . . . to.prepare.the.project.

. •. In.December,.the.Council.organised.the.fourth.joint.meeting.on.“Physical.environmental..

factors” (ionising and non-ionising radiation), in collaboration with Dutch Health Council . . . colleagues..This.meeting,.organised.alternately.by.both.councils,.has.become.a.true..

value and allows to discuss both councils’ opinions and recommendations.

. •. During.the.same.month,.at.the.invitation.of.the.Public.Health.Agency.of.Canada,..

. . the.Council.took.part.in.the.international.forum.on.the.Canadian.immunisation..

. . programme..Information.exchanged.during.the.forum.will.enable.Canadian.authorities..

. . to.evaluate.and.update.their.existing.immunisation.programme.

Audit

The.Court.of.Auditors.has.carried.out.an.audit.of.the.advisory.bodies.to.back.up.political..

decisions,.as.well.as.of.the.operations.of.these.bodies..The.Court.of.Auditors.is.carrying.out.

an audit of the Superior Health Council, the Federal Expertise Centre, the Scientific Institute . of.Public.Health.(IPH),.the.National.Institute.for.Health.and.Disability.Insurance.(NIHDI)..

and.the.FPS.Health,.Food.Chain.Safety.and.Environment..The.Council.pledged.to.provide.its.

full cooperation to the Court of Auditors and looks forward to the audit’s results.

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History

15 May 2009 is a special day for the SHC: it will celebrate its 160th anniversary (it was in fact . created by the Royal Decree of 15 May 1849). Its 150th anniversary went rather unnoticed..

That.is.why.the.Council.does.not.want.to.miss.out.on.the.celebration.of.its.160th.anniversary...

The.Council.has.therefore.started.writing.a.book,.which.will.relate.its.history..The.examination..

of.the.sources.and.the.writing.of.the.book.were.entrusted.to.a.historian,.Elisabeth.Bruyneel..

The.latter.is.backed.by.a.Support.Committee.composed.of,.among.others,.Professor.Velle,.the.

kingdom’s archivist, (co-)author of the book “Er is leven voor de dood: tweehonderd jaar gezondheidszorg in Vlaanderen” and the author of “De nieuwe biechtvaders: de sociale geschiedenis van de arts in België”.

What emerged from the examination of the sources is that the SHC had previously been involved in numerous subjects for which other specific bodies were subsequently created;

for example, purification, hygiene in schools and council housing, hospital architecture, establishments that are dangerous, unfit for habitation and inconvenient, funerals, ceme- teries,.social.legislation,.etc..

15 May 2009 will represent a turning point in the Council’s history. By then its restructuring should.be.completed:.the.experts,.members,.chairman.and.vice.chairmen.will.have.been.

appointed,.new.working.methods.implemented,.etc..It.will.be.an.opportunity.for.a.major.

celebration, which will allow to recall the “old” Council with a book dedicated to its history, but also to resolutely turn to the future, to the “new” Council, its new organisation and its new.operating.style.

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5 . PRESENTATION OF THE FIELDS AND PRINCIPAL RECOMMENDATIONS ISSUED IN 2008

5.1. Mental health

In.the.area.of.mental.health,.working.groups.provide.opinions,.recommendations.or.reports.on.

health.issues.linked.in.full.or.in.part.to.the.behaviour.of.individuals,.groups.or.the.organisation..

of.life.in.society.(psychosocial.factors)..It.comprises.more.particularly:

. •. High-risk.behaviours.involving.substance.abuse.(alcohol,.tobacco.and.drugs).and..

addictions linked to specific behaviours (pathological gambling)

. •. Psychosocial.factors.at.the.basis.of.health.issues,.leading.to.them.or.aggravating.them..

. •. Quality.of.human.relations.in.particular.in.the.area.of.healthcare.

. •. Training.of.health.professionals.in.these.matters.

In 2008, the working group, which, in 2007, had studied the prescription of psychotropic . medicines.with.respect.to.stress,.anxiety,.depression.and.sleeping.disorders.(SHC.8155),..

pursued its work. The section dedicated to depression was finalised in 2007. In 2008, the group . elaborated.this.section.dedicated.to.anxiety.disorders..These.two.reports.will.be.turned.into.

brochures intended for general practitioners in the course of 2009.

Another.working.group.has.also.carried.out.work.on.behavioural.problems.in.children.and.

adolescents (SHC 8325).

Lastly,.an.ad hoc.working.group.was.set.up.in.order.to.provide.its.opinion.on.an.information.

brochure.on.gambling.addictions.(SHC.8426).

Principal recommendations on which groups have worked in 2008:

Prescription of psychotropic medicines for stress, anxiety, sleeping disorders and depression (SHC 8155)

In 2007 the working group in charge of providing recommendations on this issue had finalised . a first section focused on depression. This section, entitled “Depression: caring for the patient . and optimal use of the care system and of the therapeutic orientations”, was for that matter presented in the 2007 annual report. However, it was not published in 2008, since the group chose.to.publish.it.at.the.same.time.as.the.second.section,.dedicated.to.anxiety.disorders..

This will probably be possible in 2009.

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Mental health

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In 2008, the working group therefore focused on the elaboration of the “anxiety disorders” section. . In.this.report.the.working.group.has.analysed.this.issue.under.its.various.aspects..In.this.way..

anxiety was broached as a specific disorder (compulsive obsessive disorder, posttraumatic . stress.syndrome,.phobias,.etc.),.but.also.as.part.of.other.pathologies.(depression,.psychotropic..

substance.abuse,.psychoses,.etc.),.or.as.the.manifestation.of.a.personality.disorder,.or.linked..

to stress or specific situations.

The.various.therapeutic.options.were.also.tackled,.since.pharmacotherapy.had.been.broadly.

described,. as. well. as. non-medicinal. alternatives. such. as,. for. example,. psychotherapies,..

relaxation techniques or support groups. The issue of benzodiazepine withdrawal was . also.discussed.in.depth,.as.well.as.support.by.an.attending.physician.(and.the.indications.

for.referral.to.a.specialist)..Lastly,.the.working.group.also.studied.the.psychological.and.

physical.repercussions.of.anxiety.and.its.special.aspects.in.children.and.adolescents..

In 2009, the section on depression will be revised in light of that written on anxiety and both.sections.will.be.published.together..

Behavioural disorders in children and adolescents (SHC 8295)

An.ad hoc working group was set up in 2007 to study the theme of behavioural disorders in children and adolescents. This recommendation is targeted at all first response health professionals.who.deal.with.children.displaying.behavioural.issues.

The. working. group. has. tackled. this. issue. in. a. very. broad. way,. attempting. to. take. into.

account.all.of.the.aspects.involved.and.to.position.itself.at.the.crossroads.of.the.areas.of.

health, justice and social pedagogy. Numerous meetings have therefore been held in 2007 and.2008.in.order.to.discuss.the.matter.from.all.angles..

Consequently,.the.group.studied.the.variability.of.manifestations.of.these.types.of.disorders.

and the diagnostic classifications, as well as the diagnostic process. It has also explored.

comorbidity.and.extensively.analysed.the.risk,.protection.and.resilience.factors.(both.biological..

and.environmental).as.well.as.the.development.trail.for.these.disorders..Lastly,.an.inventory..

of.the.various.types.of.intervention,.with.respect.to.prevention.as.well.as.treatment,.was.produced...

To this end, various players from the field came to present their work and experience in this area to . the group (Kind & Gezin, ONE, etc.). Lastly, the group also discussed the legal framework surrounding.

these.disorders.in.the.application.of.Evidence-Based.Medicine.in.the.context.of.this.issue...

The.various.working.group.meetings.also.enabled.it.to.learn.about.a.number.of.interesting.

local.initiatives.in.this.area.and.to.review.the.points.of.view.and.needs.run.into.by.the.various..

sectors.involved.(education,.infancy.reception,.justice,.police,.aid.to.young.people,.etc.)..This.will.

enable the group to elaborate concrete recommendations adapted to Belgian reality in 2009. . The.report.will.therefore.be.published.in.the.course.of.this.year.

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Physical environmental factors

16

5.2. Physical environmental factors

The.mission.of.the.working.groups.in.the.area.of.physical.agents.consists.in.formulating.opinions..

and.recommendations.aimed.at.evaluating.health.risks.associated.with.various.physical.agents..

and.their.applications..The.groups.also.proceed.to.the.evaluation.of.the.measures.aimed.at.limiting,..

to.the.extent.possible,.exposure.of.man.and.the.environment..The.area.is.split.into.two.sub-areas:.

. •.Ionising.radiation.

. •.Non-ionising.radiation.

.

In.addition.to.a.general.deliberation,.ad hoc.groups.have.been.set.up,.characterised.by.their.

major multidisciplinary nature, in order to deal with more specific issues.

The. collaboration. between. the. Dutch. Health. Council. and. the. physical. agent. deliberation.

group.was.extended.in.2008.as.part.of.the.exchange.of.ideas.as.well.as.in.the.context.of.an.

additional.peer.review..

The.chairman.and.a.number.of.experts.have.taken.part.in.the.project.“The.Spring.of..

the Environment” by Minister Paul Magnette, which has allowed to include electromagnetic radiation.and.radon.in.the.list.of.priority.questions.in.environmental.policy..

Ionising radiation

Four working groups met in 2008, i.e., the “Optimisation in nuclear medicine”, “Cremation”,.

“Radioecology” and “Regulations” working groups. The “radioecology” working group met five times.in.2008.and.primarily.studied.two.issues:.on.the.one.hand,.the.development.of.the.

European EURANOS handbook (generic European handbook for measures in the food chain);

on the other hand, the monitoring of purification stations where traces of radioisotopes can be.found..The.objective.is.to.identify.their.origin.and.to.elaborate.recommendations.aimed.

at.minimising.this.discharge.as.much.as.possible..The.advisory.report.on.liquid.radioactive.

hospital waste will be finalised in early 2009.

The “Radioecology” working group has finalised its activities – launched in 2007 – on the . EURANOS topic and on the issues linked to the planning of countermeasures in agriculture in the . event.of.radioactive.incidents.in.Belgium..A.brief.recommendation.was.developed.for.the.FANC.

(Federal.Agency.for.Nuclear.Control),.the.FASFC.(Federal.Agency.for.the.Safety.of.the.Food.Chain)..

and.the.competent.ministers.(Interior.minister,.Health.minister.and.Agriculture.minister).

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Physical environmental factors

17

In 2008, the working group “optimisation and radioprotection in nuclear medicine” has pursued . its.work.in.the.area.of.dosimetry,.impact.of.the.PET.scan.and.training.of.personnel.and..

patient information. The report is being finalised and will be issued in the first half of 2009..

The.chairman.of.the.deliberation.group.was.associated.with.the.roundtables.on.radiology,.

radiotherapy.and.on.the.cremation.of.radioactive.bodies.organised.by.the.FANC.in.order..

to.prepare.the.modifications.in.the.regulations.and.from.a.point.of.view.of.incident..

communication. On this last topic, the SHC had requested further studies from the FANC . in 2003. The latter has requested the evaluation of the results of these studies from the SHC. What emerges is that little risk is involved in the cremation of bodies likely to be radioactive, but that the notification system in the event of death must be improved for increased efficiency.

Lastly, a “regulations” working group has issued two recommendations relative to the . modification of the Royal Decree of 20 July 2001 on the general regulations for the protection . of.the.population,.workers.and.the.environment.against.the.danger.of.ionising.radiation.

(abbreviated RGPRI).

Principal recommendations issued in 2008:

Recommendation by the SHC with regard to the draft RD on import, export, transit and distribution of radioactive substances (SHC 8399)

On 20 November 2006 the Council of the European Union promulgated Directive 2006/117/

EURATOM on the supervision and control of shipments of radioactive waste and spent fuel.

The. FANC. took. advantage. of. the. obligation. to. adapt. this. Directive. to. review. a. number.

of.recommendations.concerning.the.import,.export,.transit.and.distribution.of.radioactive.

substances.

At.the.request.of.the.FANC.(Regulations.Department,.International.Activities,.Development),..

the.draft.Royal.Decree.was.submitted.to.an.ad hoc.working.group.of.the.Superior.Health.Council..

whose.mission.it.was.to.issue.an.opinion.on.this.subject,.and,.in.particular,.to.answer.the.

following.questions:

. •. Does.this.draft.RD.comply.with.good.practice.regulations.in.terms.of.radioprotection..

. . and.nuclear.safety?

. •. Does.the.draft.RD.satisfy.the.requirements.for.the.transposition.of.the.European..

Directive 2006/117/EURATOM?

. • Does the draft RD meet expectations in terms of administrative simplification?

.

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Physical environmental factors

18

The.principal.conclusions.are.as.follows:

. 1..A.difference.in.approach.is.observed.between.sealed.sources.and.unsealed.sources..

. . with.respect.to.the.necessary.authorisations.

2. A new definition for “radioactive waste” is introduced, which differs from the definition . included in the RGPRI and that used by the ONDRAF²...The.SHC.insists.that.an.end.be..

. . put.to.this.confusing.situation.

3. This text must lead to administrative simplification. The SHC recommends to further . . . stress. this. aspect. during. the. implementation.. In. this. context,. standardised. forms..

. . must.be.made.available.to.users.

. 4..The.suppression.of.the.transit.authorisation.may,.in.some.cases,.create.a.vacuum..

with respect to management. Modifying the RGPRI should eliminate this lack of clarity..

Recommendations relative to the draft Royal Decree modifying the Royal Decree of 20 July 2001 on the general regulations for the protection of the population, workers and the environment against the danger of ionising radiation (SHC 8427)

The RD of 20 July 2001 on general regulations regarding the protection of the population, workers and the environment against the danger of ionising radiation (RGPRI).

Chapter.VI,.on.medical.applications.underwent.a.thorough.overhaul.after.consultation.with.

all the parties involved in the RD of 17 May 2007.

All.of.the.general.regulations.(including.Chapter.VI).are.currently.undergoing.an.in-depth.and.

overall.review,.with.consultation.of.the.parties.involved.at.the.initiative.of.the.Federal.Agency.

for.Nuclear.Control..This.in-depth.review.is.scheduled.over.a.period.of.several.years.

The.draft.RD,.currently.submitted.to.the.SHC,.covers.a.series.of.practical.aspects,.which.

must. be. resolved. relatively. quickly.. To. a. certain. extent,. it. represents. a. kind. of. “interim.

update” of the RGPRI.

A.recommendation.by.the.Superior.Health.Council.is.required.by.the.Federal.Agency.for.Nuclear..

Control as part of these new modifications of the RGPRI.

The draft Royal Decree was submitted to the SHC on 23 June 2008. The expanded ad hoc

“Regulations” working group was requested to develop a draft recommendation on the following . issues,.among.others:

. •. Does.this.draft.RD.comply.with.good.practice.regulations.in.terms.of.radioprotection?.

. • Does the draft RD meet expectations in terms of administrative simplification?

2 ONDRAF/NIRAS is the Belgian Agency for Radioactive Waste and Enriched Fissile Materials.

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Physical environmental factors

19

The.main.remarks.issued.by.the.SHC.as.part.of.these.recommendations.are.as.follows:

- The SHC duly takes note of the FANC’s desire to fully overhaul the RGPRI in the . . . coming.years.

. -. The.SHC.believes.that.reinforcing.training.in.the.area.of.radioprotection.is.positive.but.

wonders who will finance these new training methods. In addition, a legal vacuum . . . appears.with.respect.to.the.training.of.veterinary.surgeons.

- The NORM issues must be clarified.

. -. The.SHC.suggests.making.the.suspension.and.break-up.of.activities.methods.stipulated..

in Article 17 of the RD more pragmatic.

. -. The.SHC.suggests.adding.provisions.for.parts.of.the.body.that.are.more.sensitive,..

. . such.as.the.crystalline.lens.

- Lastly, the SHC feels that Article 69.2 should be removed.

Recommendation relative to measures to be taken in the agricultural sector after potential contamination of the food chain by radioactive substances (SHC 8321)

As.a.result.of.a.nuclear.or.radiological.accident.or.during.certain.scenarios.linked.to.nuclear..

terrorism, the risk of radioactive contamination of the food chain is significant. This contamination . may.lead.to.the.population.being.exposed.to.radiation.doses,.to.problems.with.respect.to.the..

environment and major financial losses. In the past, the Superior Health Council has already . broached.this.issue:.the.document.“Measures.to.be.taken.in.the.agricultural.sector.in.the.

event of a nuclear accident” was published in 1992. In the context of the European EURANOS . research.project,.special.attention.was.paid.to.this.issue..The.result.was.a.European.handbook..

on.the.approach.to.radioactive.contamination.of.the.food.chain..A.recommendation..

was developed as a result of this publication. This recommendation makes no scientific . claims, but aims to promote the implementation of the EURANOS handbook in Belgium and.the.collaboration.between.the.FASFC.and.the.FANC.

Recommendation of the Superior Health Council on the issue of cremation of bodies carrying radioactive sources (SHC 8416)

In 2003 the Superior Health Council issued advisory reports and recommendations on the dispersion.of.radioactivity.from.sources.used.for.medical.purposes.and.carried.by.deceased.

patients (SHC 5110/3). In compliance with recommendations issued in this advisory report, . the FANC has conducted a field study (RASO) to provide a more complete answer to . the questions posed. On 21 April 2008, the FANC requested the Superior Health Council’s interpretation.of.the.results.of.this.study.and.asked.it.to.check.if.certain.recommendations.

from.the.previous.report.must.be.reviewed.

Annual report 2008

Physical environmental factors

20

The.SHC.believes.that.the.recommendations.provided.in.its.previous.report.are.of.a.nature.

to efficiently protect the personnel in charge of cremation operations and the population and that consequently the Directive need not be modified in its technical aspects.

Even.though.the.results.of.the.study.are.reassuring,.it.must.be.noted.that.the.obligatory.

notification system is faulty: no case has been notified during the period of the study (except for.the.case.study.of.the.patient.with.I-125.seed.implants)..This.could.have.an.impact.not.

only.at.the.time.of.cremation.but.also.on.any.step.between.death.and.the.transfer.to.the.

crematorium. An improvement in the notification process is the best way to optimise this type.of.practice.

In order to improve the notification process, the Superior Health Council therefore advises the.FANC,.competent.in.terms.of.radioprotection,.to.inform,.through.the.means.it.considers..

opportune,.the.regulatory.authorities.in.charge.of.these.various.materials,.notably,.the..

regional. ministers. with. the. competence. for. making. funeral. arrangements,. the. governors.

and/or mayors for administrative acts, the medical profession and, through their professional . organisations,.operators.of.funeral.homes.and.crematoriums.

Lastly,.with.respect.to.this.issue,.the.SHC.recommends.that.the.FANC.suggest.to.the.competent..

minister a modification of section C of the death certificate provided in the RD of 17/06/99 in.order.for.matters.relative.to.the.presence.of.radioactivity.in.dead.bodies.to.be.simpler.and.

lead.to.fewer.questions.on.the.part.of.the.reporting.doctor.

Non-ionising radiation

The “Non-ionising radiation” working group has pursued its activities launched in 2007. . The reports on low-frequency electromagnetic radiation, and more specifically, on the issue of modulated and pulsed waves as well as exposure to magnetic fields emanating from electrical . appliances, were finalised. In addition, an overview of the opinions issued during the past eight.years.on.non-ionising.radiation.was.developed..

In.November,.the.deliberation.group.met.in.order.to.prepare.the.joint.meeting.with.the.

Netherlands.and.to.discuss.the.development.of.recommendations.at.international.level.

(ICNIRP³.recommendations,.among.others)..These.discussions.were.made.possible.thanks.to.

the.participation.of.the.members.of.the.working.group.in.numerous.international.congresses...

3 ICNIRP stands for International Commission on Non-Ionising Radiation Protection.

Annual report 2008

Physical environmental factors

21

In December, as part of the discussions on the decrease of the standard for GSM antennas, . Minister Laurette Onckelinx and Minister Paul Magnette have invited a working group delegation, . to.come.to.the.Cabinet.in.order.to.clarify.the.opinions.it.issued.in.2008.

Principal recommendations issued in 2008:

Exposure of the population to magnetic fields from electric facilities (SHC 8081)

In.accordance.with.the.precautionary.principle,.the.Superior.Health.Council.has.issued.this..

advisory report following the classification (2B) of the magnetic fields (50 or 60 Hz) as . potentially.carcinogenic.(childhood.leukaemia),.established.by.the.International.Agency.for.Research..

on.Cancer.(IARC),.and.information.in.literature.for.which.some.uncertainty.still.exists,.however...

Taken.into.account.this.information.and.uncertainty,.the.Superior.Health.Council.feels.that.

exposure to magnetic fields from electric facilities must be limited, especially in children.

Prolonged.exposure.of.children.under.15.years.old.should.not.exceed.the.mean.value..

of.0.4.microtesla.(µT)..This.exposure.involves.all.usual.places.of.residence.of.the.child..

(care.home.or.institution.and.school).

In.this.report,.the.Council.presents.a.number.of.simple.measures.allowing.to.implement.

these.recommendations..The.following.must.be.taken.into.account:

- The location of the place of residence, and in particular the child’s bedroom, with . . . respect.to.public.electric.facilities.(distribution.lines.and.cables,.transformation.stations)...

- The location of the bedroom and in particular the child’s bed, with respect to certain . . . aspects.of.the.electric.facility.and.equipment.operating.uninterruptedly.

However,.the.Council.considers.that.the.use.of.protective.materials.or.procedures.for.a.home..

or a single room against magnetic fields makes little sense given that these methods typically . prove to be fairly inefficient and costly.

To.the.extent.possible,.the.Council.recommends.taking.into.account.the.distances.required.

when.choosing.the.location.of.any.new.public.electricity.facility.and.favour.underground.

high-voltage.lines.

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Physical environmental factors

22

Potential biological effects of modulated microwaves (SHC 8194)

In.this.advisory.report.the.Superior.Health.Council.answers.the.following.question:.Can.exposure..

to pulsed and modulated radiofrequency fields and to microwaves have a negative impact on.health?.These.microwaves.primarily.result.from.wireless.communication.technologies,.to.

which.the.population.is.increasingly.exposed..

The.slow.variation.due.to.an.amplitude.modulation.is.a.technical.property,.which.could..

potentially.have.an.impact.on.biological.systems..In.order.to.have.an.impact,.however,.it.is.

necessary.for.the.modulated.signal.to.undergo.demodulation.in.the.biological.system..Even.if,..

to.this.date,.the.mathematical.approach.used.in.the.appendices.has.not.been.proven.experimentally,.

it.shows.it.is.highly.likely.that.the.biological.systems.demodulate.and.therefore,.be.under.the..

influence of ELF (Extreme Low Frequency) resulting from pulsed and modulated waves.

In.the.past.few.years,.an.increasing.number.of.studies.suggest.biological.effects,.but.it.is.not.

yet.possible.to.speak.of.unambiguous.evidence..Various.studies.show.effects,.whilst.others.

do not show any or are unable to confirm the effects shown in the initial studies referred to. . Effects.on.complex.biological.systems.(volunteer.animal.models).are.subject.to.interpretation..

notably due to the diversity of neutralising defence mechanisms and the difficulty of proving cumulative long-term effects. Studies of the population are difficult to conduct due to statistical . requirements..It.is.therefore.obvious.that.the.technological.evolution.in.terms.of.wireless..

communication is a huge step ahead of scientific research on its potential effects. The existence . of.a.number.of.indications.of.biological.effects,.even.health-related.effects,.however,.prompts.

caution and makes subsequent follow-up and scientific research necessary.

Overview of advisory reports 2000-2008 (SHC 8433)

The Superior Health Council regularly studies the scientific status of the situation as regards the.health-related.effects.of.non-ionising.electromagnetic.radiation..The.aim.of.this.publication..

is.to.provide.an.overview.and.to.check.the.consistency.of.the.various.recommendations.issued..

by.the.Superior.Health.Council.in.the.area.of.non-ionising.radiation.since.2000..

Health impact of high-frequency sounds produced by the Mosquito device (SHC 8415)

On 15 April 2008, Minister Laurette Onkelinx requested the Superior Health Council to answer . questions relative to the use of the Mosquito device, marketed in order to fight the nuisance of

“young undesirables”, which involved the impact of this device on physical and psychological . health..

The Mosquito produces a high-frequency pulsed sound signal (16 – 20 kHz), in practice only audible . by.adolescents..Information.available.on.the.subject.of.the.harmfulness.of.high-frequency..

sounds (8 kHz – 20 kHz) is rare.

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Physical environmental factors

23

Given available data, the Superior Health Council feels that there is no danger whatsoever of hearing.damage.among.adults.and.adolescents.resulting.from.exposure.to.the.sound.made.

by.the.Mosquito..However,.the.impact.on.the.foetus.and.on.infants.is.not.known..Prolonged.

exposure.in.pregnant.women,.young.children.and.infants,.should.therefore.be.avoided.

There is no scientific literature discussing the impact of high-frequency sounds and ultrasounds on.psychological.health..Despite.the.absence.of.scientific.evidence.on.the.consequences..

of. the. Mosquito. on. the. psychosocial. health. of. young. people,. experts. have. formulated. a.

number of important observations. It is highly unlikely that the Mosquito is efficient in the long.term,.since.it.represents.an.aversive.stimulus,.which.often.leads.to.a.habituation.effect...

In.addition,.the.risk.exists.that.the.Mosquito.is.perceived.as.a.provocation.and.might.lead.to.

aggressive.behaviour..Better.alternatives.could.be,.among.others,.the.creation.of.meeting.

spaces.and.peer.intervention..Lastly,.it.must.be.said.that.this.also.represents.an.ethical.

debate for which it must first be clearly established what the issue is.

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Chemical agents

24

5.3. Chemical agents

In 2007, the responsibility for the risk evaluation for pesticides and biocides was moved for the most.part.from.national.to.European.level..The.primary.evaluation.of.dossiers.at.national.level.

is.currently.taking.place.within.committees:.The.Committee.for.the.Approval.of.Pesticides..

for.Agricultural.Use.and.the.Advisory.Committee.on.Biocides.(CAB).

The SHC was therefore given a second-line role and is only consulted at the administration’s request.

In.2008,.the.working.group.evaluated.European.monographs.drawn.up.by.Belgium.on.the.

subject.of.pesticides.for.agricultural.use.or.biocides.(2.dossiers).

As.part.of.the.pesticide.evaluation.process,.it.has.heared.a.company.this.year.

The SHC has also examined appeals filed by a company following a (negative) advice by the CAB, as provided by Article 7 of the Royal Decree of 22 May 2003. In 2008, the SHC processed . 5.appeals.and.communicated.its.recommendations.to.the.Minister.within.the.legally.imposed.

deadlines.

Pesticides.and.biocides.are.not.the.only.dossiers.submitted.to.the.working.group;.questions.on..

the.risks.of.exposure.to.chemicals.can.also.be.posed..In.2008,.the.administration.sought.the..

working group’s opinion as to the potential health impact on the population and on the . environment.following.an.episode.of.mercury.in.air.pollution.in.the.Brussels.region.(SHC.8406)...

The working group also studied the methodology, established by the VITO, simulating scenarios . of.exposure.to.substances.such.as.deodorants.and.combustion.products.in.order.to.assess.

the.danger.in.homes.(SHC.8165).

The group’s opinion was also sought by the Minister on a study carried out by Test-Achats magazine revealing the presence of various toxic substances in a number of children’s pyjamas . (SHC.8424).

The.working.group.also.treats.other.health.issues.at.the.same.time,.related.to.the.presence.of..

substances.in.the.workplace.and.in.the.environment.(Draft.Royal.Decree.on.batteries.and..

accumulators as well as waste from batteries and accumulators and repealing the RD of 17 March . 1997 on batteries and accumulators containing certain dangerous substances – report n° 8407;.

Draft Royal Decree modifying the RD of 12 October 2004 on the prevention of dangerous substances . in electrical and electronic equipment – SHC 8418).

Lastly,.initiatives.can.be.taken.within.the.working.group.in.order.to.study.health.issues.due.

to.the.exposure.to.environmental.chemical.factors.

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Chemical agents

25

Principal recommendations issued in 2008:

Toxic chemicals in children’s pyjamas – report n° 8424

A.study.carried.out.on.the.Belgian.market.by.Test-Achats magazine revealed that three pyjamas . out.of.15.tested.for.the.potential.presence.of.toxic.substances.(notably.phthalates,.formaldehyde,..

dyes, benzene and heavy metals) contained very high values for a number of substances, even . banned.dyes.

This.study.emphasises.the.absence.of.Belgian.and.European.standards.in.this.matter.

Questioned on the subject, Minister Laurette Onkelinx requested the Superior Health Council’s . advice.on.a.series.of.questions.relative.to.this.study.

The.Council.observes.that.an.in-depth.analysis.of.the.toxicity.of.the.analysed.substances.

would be useful, but that this goes beyond the mission and possibilities of the SHC’s ad hoc working.group.

As.to.the.standards.relative.to.the.concentration. of.potentially.dangerous.substances.in.

textiles,.the.SHC.experts.have.concluded.that.they.are.effectively.quite.limited.and.that.it.

is sometimes difficult to back them up scientifically. An extension of the existing standards is.desirable.but.should.preferably.be.implemented.in.consultation.with.European.regulatory.

bodies.

Current legislation allows – at least partially – Belgian authorities to intervene in such a case . (i.e..withdraw.a.number.of.products.from.sale.in.the.event.that.reasonable.exposure.limits.

are.exceeded)..In.addition,.the.industry.could.be.asked.for.more.self-regulation,.or.a.more..

restrictive.regulatory.framework.could.be.implemented..The.latter.hypothesis.implies.checking..

and.execution.procedures,.notably.the.allocation.of.responsibilities.

.

Annual report 2008

Diet, nutrition and health...

26

5.4. Diet, nutrition and health, including food safety (NASSA)

As.part.of.normative.policy.of.the.Federal.Public.Service.for.Health,.Food.Chain.Safety..

and.Environment,.the.permanent.NASSA.working.group.is.called.on.for.risk.evaluations.of.

additives, chemical or microbiological contaminants of new ingredients or foodstuffs (NA/NF

“Novelfoods”), etc.

In. addition,. as. part. of. the. nutritional. policy. of. the. FPS,. it. not. only. issues. nutritional..

recommendations.on.which.projects.such.as.the.NNHP-B.(National.Nutrition.and.Health.Plan.

for.Belgium).have.to.rely,.but.also.recommendations.concerning.the.labelling.of.marketed.

products,.their.nutritional.and.health.claims,.the.features.of.certain.products.such.as.those.

concerning.special.diets.

The.NASSA.working.group.is.part.of.the.European.Food.Safety.Authority.(EFSA).network.

(network of organisations operating in the fields within the EFSA’s mission EC Regulation 178/2002).

It is also represented by one of its members within the ESCO (European Scientific Cooperation), . a working group on the analysis of risks and benefits due to the enrichment of foodstuffs with.folic.acid.

The working group deliberated on the issue of the specific role it plays when facing other existing scientific advisory bodies within federal authorities. The spreading of competences . between the SHC and the SciCom (Scientific Committee) of the Federal Agency for the . Safety.of.the.Food.Chain.(FASFC).is.established.in.a.protocol.signed.in.early.2006..Even.if.the..

contacts between both Belgian scientific advisory bodies are not new and that a number of scientific experts sit on both bodies, it is useful to increase these contacts and to pursue structured.bilateral.consultations.in.order.to.implement.the.protocol,.clarify.the.missions,.

anticipate.synergetic.interaction.and.identify.potential.problems..

Numerous.recommendations.by.the.working.group.are.issued.following.an.evaluation.request..

by.the.Foodstuffs.Division.and.other.consumption.products.of.the.Federal.Public.Service..

for.Health,.Food.Chain.Safety.and.Environment..In.the.majority.of.cases,.the.dossiers..

submitted contain confidential data, which cannot be communicated in this annual report.

In.2008,.the.working.group.notably.examined.dossiers.on.food.supplements.(5),.a.request..

seeking.recognition.of.natural.mineral.water,.an.authorisation.request.for.the.use.of.polyethylene..

terphthalate.(PET).recycled.in.materials.in.contact.with.foodstuffs,.etc..

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The working group also issues advisory reports – on its own initiative or upon request – of a . non-confidential nature, which may be published. This was the case, in 2008, notably for the exclusive sale in pharmacies of infant formulas (SHC 8434). The SHC also published . its report n° 8290 on nitrates in Belgian endives, celery and lamb’s lettuce the . publication of the RD of 18 September 2008, repealing the RD of 15 February 1989 laying down.the.maximum.nitrate.content.of.certain.vegetables..The.working.group.also.studied..

a.previously.issued.report.on.contaminants.in.eggs.from.chickens.bred.by.private.individuals.

(SHC.8126)..

The working group has – on its own initiative or upon request – broached various topical issues: acrylamide, 3-MCPD esters, aspartame, the enrichment of foodstuffs with folic acid, cosmetic.surveillance.monitoring,.NNHP-B.follow-up,.melamine,.nanotechnologies,.etc.

It questioned the distribution practice, in maternity wards, of “baby trouss” (kits with cosmetic . products.for.babies,.among.others).and,.in.this.respect,.has.drafted.a.note.for.the.Committee..

The NASSA working group is in charge of evaluating “NovelFoods” (NF/NA) for Belgium (except . for GMOs) with respect to regulation (EC) no. 258/97 of the European Parliament and the . EU Council of 27 January 1997 on new foodstuffs and new food ingredients. These regulations . apply.to.the.marketing.within.the.Community.of.foodstuffs.and.food.ingredients.for.which.

human.consumption.has.been.negligible.so.far.within.the.Community..The.request.for.the.

authorisation.to.market.a.new.foodstuff.(novelfood).is.submitted.by.the.applying.company.

in.a.Member.State..This.country.is.obliged.to.proceed.to.an.evaluation.of.the.submitted.

dossier and to draft an initial evaluation report within three months (first-line evaluation).

This.report.is.subsequently.transmitted.to.the.other.Member.States,.which.have.60.days.to.

issue.remarks.on.the.report.(second-line.evaluation)..In.2008,.the.working.group.examined.

and evaluated 5 first-line NF/NA dossiers. Eleven second-line dossiers are pending.

.

Several.projects.put.forward.by.the.working.group.were.pursued.in.2008,.notably.the.projects..

“Review of Nutritional Recommendations for Belgium” (SHC 8309), “Safety of Oils and Fats”

(SHC 8310) and “Evaluation of the exposure to risks linked to the natural presence of certain . contaminants in natural mineral waters” (SHC 8311).

In addition, the working group has elaborated on “Additives and (pseudo)-allergies” (SHC 8513) . on the one hand, and on “Palm oil” (SHC 8464) on the other hand. It is also involved in a recommendation.on.alcohol.and.pregnant.women.(SHC.8462).

.

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Diet, nutrition and health...

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Principal recommendations issued in 2008:

Nutritional recommendations for Belgium – revised (SHC 8309)

A.group.of.experts.in.charge.of.the.new.review.of.nutritional.recommendations.for.Belgium.

has.re-evaluated.all.the.chapters.in.the.fourth.edition.(published.in.November.2006)..Special.

attention.was.paid.to.the.chapters.on.the.nutritional.content.of.mineral.salts,.trace.elements.

and vitamins, which were completely rewritten on the basis of the most recent scientific publications..The.energy.and.protein.intake.in.children.and.the.intake.of.certain.trans.fatty.

acids.have.also.been.re-evaluated.

The.enrichment.of.foodstuffs.with.certain.nutrients.is.also.broached.in.this.new.version.of.

nutritional.recommendations.

As.the.previous.ones,.these.recommendations.concern.the.recommended.intake.of.nutrients...

These fundamental nutritional concepts constitute the scientific basis necessary for the transposition.into.recommended.food.intake..This.new.edition.should.represent.a.reference.

tool for any practitioner or teacher in the field of nutrition, as well as for those in charge of the.food.industry.and.of.diets.in.communities..

Publication is scheduled for the first quarter of 2009.

Safety of oils and fats – quality criteria and toxicological aspects (SHC 8310)

. Recommendations.for.a.better.balanced.lipid.diet.led.to.the.current.development.of.oils..

and numerous products enriched in polyunsaturated fats, in particular omega-3 fatty acids.

Whilst the nutritional benefits from these products are proven, new health risks could result from.a.lack.of.control.along.the.production.chain.through.to.the.consumer.given.the.sensitivity..

of.said.products.to.oxidation..More.generally,.oil.and.oxidation.and.deterioration.issues,..

in.particular.frying.oils,.seem.to.represent.health.risks.and.it.is.necessary.to.be.able.to.assess..

them.and.take.adequate.measures.in.terms.of.control.and.prevention..The.project.is.aimed.at.

analysing.criteria.with.respect.to.the.instability.of.oils.and.fats..The.objective.is.to.identify.the.

most.relevant.criteria.in.terms.of.consumer.health.risks,.in.addition.to.potential.contaminants...

In.2008.several.chapters.were.drafted,.notably.concerning.factors.impacting.the.oxidation.

of.fats,.the.toxicity.of.lipid.oxidation.products,.the.identity.and.formation.of.the.relevant..

lipid.oxidation.products.toxicologically.as.well.as.an.explanatory.appendix.concerning.the.

metabolism.of.lipids..A.chapter.on.technological.aspects.and.another.on.risk.analysis.have.

been started. The project will be finalised in 2009.

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Evaluation of the exposure to risks linked to the natural presence of certain contaminants in natural mineral waters (SHC 8311)

The aim of this project, launched at the administration’s request (DG 4), is to establish . an overall evaluation of the level of exposure of the Belgian population to fluoride through natural.mineral.waters..The.mission.of.the.working.group.in.charge.of.the.project.was.rapidly..

expanded..The.sources.of.exposure.were.expanded.to.include.all.of.the.relevant.exposure.

sources.(tap.water,.certain.foodstuffs,.toothpastes,.etc.)..In.2008,.the.working.group.pursued..

the collection of data relative to the fluoride content of natural mineral waters and tap waters. . It.also.collected.consumption.data.relative.to.these.ingestion.sources.for.the.adult.population..

as well as for children (2.5 – 6 years). An evaluation of the ingestion of fluoride was launched . by.combining.both.types.of.data.(deterministic.approach)..The.experience.acquired.during.

the study of fluoride exposure will subsequently facilitate that of the exposure to other mineral . elements. The project will be finalised in 2009.

Exclusive sale in pharmacies of infant formulas (SHC 8434)

As.part.of.the.National.Nutrition.Health.Plan.(NNHP),.the.appropriateness.was.discussed..

of.implementing.regulations.aimed.at.the.exclusive.sale.in.pharmacies.of.infant.formulas..

The.debate,.which.took.place.from.the.end.of.2006.to.May.2008,.did.not.lead.to.a.conclusion..

either.way..In.the.absence.of.a.consensus,.the.members.of.the.main.panel.of.experts.of.the.

NNHP.have.suggested.requesting.the.advice.of.the.Superior.Health.Council.on.the.entire.

dossier.

.

Infant formulas (IF) are not medicines and current legislation does not impose a specific . distribution method for IF intended for children in good health during the first three months . of.life..However,.legislation.imposes.numerous.requirements.on.this.distribution.with.respect..

to.composition,.fabrication,.labelling.and.advertising,.banning,.among.others,.any.comparison..

with.breast.milk.or.breast.feeding.

The SHC believes that the distribution of IF for the first three months of life in pharmacies . tends.to.provide.a.maximum.of.guarantees.including.the.knowledgeable.advice.of.an.academic..

sensitised.and.trained.in.health.and.nutrition.issues.

It is, however, up to the public authorities to take a final position, in the mere interest of the health . of.infants,.taking.into.account.recommendations.formulated.by.the.various.bodies.consulted..

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Diet, nutrition and health...

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Food microbiology

In. order. to. deal. with. the. questions. relative. to. food. microbiology,. a. stable. working. group.

meets periodically depending on the submitted requests. This group’s activities are directly linked.to.the.regulations.and.information.concerning.the.microbiological.health.of.foodstuffs..

Throughout 2008, two specific sub-groups have been working on the elaboration of documents . of.primary.interest:

. • A first work relative to the issue of the Bacillus cereus in foodstuffs (SHC 8316 “Risk . profile of the Bacillus cereus group implicated in food poisoning”). Work carried out . throughout 2008 led to the drafting of a voluminous scientific report in English (80 pages)..

. . The.latter.will.be.summarised.and.an.abridged.version.(in.French.and.Dutch).will.be..

published on the SHC website in early 2009. It will also result in two scientific publications . . . in.specialist.periodicals.

. • A second dossier relative to the issue of the presence of viruses in foodstuffs (SHC 8386 . Viruses and food). By the end of 2008, the activities of this specific sub-working . group led to the elaboration of a scientific report (60 pages) drawn up in English. . . . A.summary.(in.French.and.Dutch).will.also.accompany.the.publication.of.this.document..

on the SHC website. It will subsequently lead to a scientific publication in a Belgian . . . medical.journal.

In 2007, the group issued a recommendation, together with the scientific committee (SciCom) . of the FASFC, concerning medical certificates for persons involved in the production, processing, . transformation and handling of foodstuffs (SHC 8207 detailed in the previous annual report).

In.the.course.of.2008,.this.joint.SHC-SciCom.group.met.again.and.has.worked.in.concert.in.

view.of.the.elaboration.of.both.brochures.whose.publication.had.been.considered.desirable.

in.this.previous.joint.recommendation..

More.concretely,.it.is.an.explanatory.brochure.targeted.at.doctors.(attending.physicians,..

occupational.physicians.and.consulting.physicians.linked.to.health.insurance.companies).and.

an explanatory brochure for operators. At the end of 2008, a first version of the brochure . for.doctors.was.submitted.to.a.group.of.practitioners.for.initial.evaluation..The.brochure..

aimed.at.operators.will.be.elaborated.later;.its.editorial.content.will.be.less.medical..

and more specifically aimed at this specific socio-professional category. After validation, these.two.brochures.(for.practical.use).will.be.published.on.the.websites.of.the.two.relevant.

organisations.

Annual report 2008

...including food safety (NASSA)

31

Practically and efficiently, the working group “Food microbiology” collaborates with the . Foodstuffs,.animal.feed.and.other.consumption.products.division.of.the.Federal.Public.Service,..

Health,.Food.Chain.Safety.and.Environment.in.order.to:

. -. Contact. experts. involved. in. certain. areas. (as. part. of. the. activities. of. the. Codex..

alimentarius) and relevantly disseminate very specific information.

. -. Be.kept.informed.of.the.steps.taken.by.the.FPS.(at.European.level).on.the.basis.of..

. . advice.provided.by.the.SHC,.such.as,.for.example:.The.Rapid.Alert.System.(RAS).for..

Campylobacter in carcasses (Article 14 of the (EC) Regulations no. 178/2002) and . . . the.(EU).reference.study.conducted.in.2008.on.Campylobacter.for.carcasses.in.the..

slaughterhouse (Belgian data) (EFSA request, BIOHAZ panel).

. -. Etc.

The working group looks forward to this profitable collaboration.