1. Introduction - European Commission (2023)

1. BACKGROUND

The possibility of introducing security scanners on the listof eligible screening methods and technologies for screeningpersons was first proposed to the Council and the EuropeanParliament on 5 September 2008 on the basis of the positive voteof the Member States' aviation security experts.

On 23 October 2008, the European Parliament adopted aresolution on the impact of aviation security measures andsecurity scanners on human rights, privacy, personal dignity anddata protection, requesting a more in-depth assessment of thesituation, opposing the Commission's proposal. The Commissionagreed to review these matters further and withdrew securityscanners from its original legislative proposal. The draftlegislation became Commission Regulation (EC) No 272/2009 toapply as of 29 April 2010.

The Commission consulted with all parties concerned and issueda first analysis on the use of security scanners: theCommunication to the European Parliament and the Council on theuse of security scanners at EU airports of 15 June 2010.Following this Communication an in-depth impact assessment wascarried out by the Commission. It concluded that securityscanners are an effective method for the screening of passengersand should be authorised for use at EU airports under certainoperational conditions and detection performance standards. Thereport also identified the need to avoid any risks to humanhealth and to ensure the protection of fundamentalrights.

Consequently, the Commission proposed to add security scannersto the list of the methods for the screening of passengers andlinked their use to a number of conditions. On 10 and 11November 2011 the Commission adopted this legislation. Therelevant elements of the package are contained in Regulations1141/2011 and 1147/2011. In particular, under the newlegislation security scanners are not mandatory for MemberStates and/or airports and can only be used at EU airports inaccordance with minimum conditions such as: security scannersshall not store, retain, copy, print or retrieve images; anyunauthorised access and use of the image is prohibited and shallbe prevented; the human reviewer analysing the image shall be ina separate location and the image shall not be linked to thescreened person and others. Passengers must be informed aboutthe conditions under which the security scanner control takesplace. In addition, passengers are given the right to opt out ofa control with scanners and be subject to an alternative methodof screening.

In order to safeguard citizens' health and safety, at thisstage, the Commission has allowed Member States and/or airportsto deploy only security scanners which do not use ionisingradiation.

The methods currently allowed for passenger screening are laiddown in point 1 of part A of the Annex to Commission Regulation(EC) No 272/2009 and are as follows:

1. Hand search;
2. Walk-through metal detection (WTMD) equipment;
3. Hand-held metal detection (HHMD) equipment;
4. Explosive detection dogs;
5. Explosive trace detection (ETD); and
6. Security scanners which do not use ionisingradiation.

Commission Regulation (EU) No 185/2010 of 4 March 2010 laysdown detailed measures for the implementation of the commonbasic standards on aviation security. Point 4.1.1.2 of the Annexdetermines that passengers can be screened by a hand search orby a walk-through metal detector. Additional requirements oncombining different methods in order to achieve effectivedetection are included in EU security restrictedlegislation.

In the EU, some countries tested security scanners and havenow introduced security scanners under the new rules. In thecurrent international context, security scanners are beingdeployed at airports worldwide, especially in the USA whereseveral hundred security scanners are currently in use. Russiahas been using security scanners at airports since 2008 and willcontinue to deploy them more widely in the future. Othercountries are either planning (e.g. Canada, Australia) orexamining the possibility of introducing security scanners (e.g.Japan).

Four main security scanner technologies for passengerscreening are currently on the market but this does not precludeother technologies from appearing:

While X-ray based security scanners are currently used in theUSA and as a trial in one UK airport, several Member States(e.g. Italy, France, Germany and Austria) prohibit the use ofionising radiation fornon-medical purposes.

The protection of workers and the general public from ionisingradiation isregulated under Directive 96/29/EURATOM. Article 6 of thisDirective specifies the basic principles of radiationprotection, among them that "Member States shall ensure thatall new classes or types of practice resulting in exposureto ionising radiation are justified in advance of beingfirst adopted or first approved by their economic, social orother benefits in relation to the health detriment they maycause." According to the Directive, the uses of X-raysecurity scanners are notified to the National CompetentAuthorities (Art. 3) and an authorization shall be required bythe Member States (Art. 4). The Directive also sets cumulativedose limits for workers (Art.9) and for members of the public(Art. 13).

As indicated in the recently adopted legislation on securityscanners, the Commission would like to receive information onthe impact on human health of the technologies available on themarket and in particular on the X-ray based security scannertechnologies.

2. TERMS OF REFERENCE

The SCENIHR is asked:

1. To assess the potential health effects related to the useof all types of security scanners used for passenger screeningwhich emit ionisingradiation.

2. If any effects are identified under 1, to quantify therisks and, if feasible, to estimate the additional number ofcases of diseases that are expected to occur in Europe due tothe use of this technology at EU airports, differentiatingbetween the general public and exposed workers as indicatedbelow.

In its assessment, the SCENIHR is asked to consider inparticular the risk for populations that are regularly exposedto such technologies (e.g. frequent flyers (to be defined), aircrew, security workers operating the scanners and other airportstaff) and potentially vulnerable groups (e.g. pregnant women,children).

The SCENIHR should compare the relative risk of such securityscanners using X-ray based technologies to other securityscanner technologies on the market.

As health protection against ionisingradiation falls underthe provisions of the Euratom Treaty, the SCENIHR is asked toconsult in its assessment the Group of Scientific Expertsreferred to in Article 31 of the Euratom Treaty (Art. 31 GoE),advising the Commission on radiation protection matters.

3. SCIENTIFIC RATIONALE

3.1 Introduction and scope

To assess the potential harm, considering the link betweenradiation exposureand health risks, we need to estimate the amount of exposure ofthe various exposed groups due to the use of security scannersfor passenger screening. As specified in the Terms of Reference(section 2.), this opinion considers only the use of securityscanners using X-ray technology at EU airports and deals onlywith radiation detriment. Justification of practices usingionising radiation as required by radiation protectionlegislation is beyond the remit of this opinion.

Ionising radiation isubiquitous and everyone is continuously exposed to it. AllEuropeans receive on average 1 mSv annually from backgroundradiation from naturally occurring radionuclides in the groundand within the body. Another component of natural radiation iscosmic radiation from space. In addition, we are exposed toindoor radon throughinhalation to a widely varying extent (range 0.1-10 mSv). Thepredominant man-made sources of radiation are medical,diagnostic and therapeutic applications with a wide range ofdoses resulting in a contribution of between approximately 20and 50% of the collective dose to the population in the EU. Thecollective dose is computed from the product of the irradiatedpopulation and the average effective dose per person. Theaverage effective dose per person due to diagnostic medicalexposures has been estimated as 0.3-0.4 mSv in the UK and1.8-2.5 mSv in Germany, while the average effective dose perperson due to natural sources varies within Europe (as describedabove) with a median of about 2 mSv. The population averagedoses from therapeutic applications have not been determinedbecause they only affect a small number of people, even if thesepeople receive very high doses. (REF SPIE paper)

At exposure levels above hundreds of mSv, adverse healtheffects of ionisingradiation have been wellestablished. The current model for estimating risk of low doseionising radiation (commonly defined as approximately 100 mSv)is based on linear extrapolation from experimental andepidemiological data obtained at higher doses. The assumptionsconcerning the shape of the dose-response curve [Query? – JudyBurns] are crucial for the assessment. A monotonic linearpattern (linear, no-threshold model) is commonly used, which isassumed to represent a prudent choice, because at very low dosesand dose rates the effects become indistinguishable from thebackground. X-radiation is a form of sparsely ionising radiationcalled low Linear Energy Transfer (LET) radiation. Presentestimates of the long-term health effects of radiation exposure,such as cancer risk, aredescribed in the International Commission for RadiationProtection (ICRP) publication 103 and are based largely on theaverage exposure to a population. Based on the recommendationsof the ICRP (ICRP 1998), radiation cancer risks relative to thebaseline are judged to be small at low doses up to a few mSv.Cancer risks at effective doses of the order of 1 µSv, such asthose encountered in passenger security-scanners using X-rays,are unknown. It is unlikely that epidemiological studies orexperimental studies with the present methodologies could, atsuch low doses, have a sample size large enough to providesufficient statistical precision and power to distinguish theincrement for determining risk estimates. At doses below 50 mSv,epidemiological studies have so far been unable to provideinformation on the shape of the dose-response curve for cancerrisk although some guidance can be obtained from experimentalstudies at doses above 1 mGy. However, for risk assessmentpurposes, the ICRP assumes a linear dose-response relationship,with no lower threshold below which radiation would have nodetrimental effect.