A6 Equality Impact Assessment

Summary of negative impacts for each group:

There have been concerns raised with regard to potential impacts of the use of some forms of energy-efficient lighting, in particular Compact Florescent Lamps (CFLs) and halogen lamps, on those with pre-existing photo-sensitive conditions.

There is little evidence to suggest directly that these lamps when used in non-directional domestic lighting situations present a health issue for the public at large.  However the Health Protection Agency (HPA) found that some open type CFLs emitted ultra violet light radiation and has issued advice to the general public on using open type CFLs in certain close working situations¹.  For these situations the HPA issued precautionary advice that the doubly encapsulated type of CFL should be used.

However some support groups have expressed concern that the following conditions can be affected by the use of low-energy bulbs on the market even with normal usage: xeroderma pigmentosum, lupus, migraine, epilepsy, myalgic encephalomyelitis, Irlen-Meares syndrome, fibromyalgia, electrosensitivity, AIDS/HIV, dyspraxia, and autism.

After pressure from the UK and patient support groups, the European Commission’s Scientific Committee on Emerging and Newly identified Health Risks (SCENIHR) considered the health impact of low energy lighting, in particular CFLs, in its Opinion on Light sensitivity issued on 23 September 2008² in order to ensure that the proposed EU measures fully considered these issues.  SCENIHR did not find suitable direct scientific data on the relationship between energy saving lamps and the symptoms in patients with various conditions.  Of all compact fluorescent lamps properties, only UV/blue light radiation was identified as a potential risk factor for the aggravation of the light-sensitive symptoms in some patients with such diseases as chronic actinic dermatitis and solar urticaria.  SCENIHR commented that, due to the lack of relevant data, the number of all light sensitive patients in the European Union, who might be at risk from the increased levels of UV/blue light radiation generated by CFL is difficult to estimate.  However, a preliminary rough estimation of the worst-case scenario yields a number of maximum 250,000 individuals (0.05% of the population) in the EU, which equates to a maximum 30,000 people in the UK.

The Department of Health (DoH) mot recently conducted a search on Pubmed on 24 November 2008 for published information on low energy light bulbs and whether there was any connection with age, disability, faith or religion, gender/transgender, race, sexual orientation or working patterns.  The search did not reveal any direct relationship.  Neither was there any relationship of these criteria with compact fluorescent lights light bulbs or halogen light bulbs specifically.  Therefore we investigated each clinical condition mentioned by the support groups for information on equality criteria.

Lupus

Lupus UK³ reports that there are around 50,000 people with lupus, a disease of the immune system, in the UK.  The prevalence is around 1 in 1000 overall, however the prevalence in women is ten times that in men⁴.  Lupus has also been reported to be more common in African-American, Afro-Caribbean, Native American, Asian Indian, Polynesian and Chinese populations compared with those of European descent⁵.  We need to seek further information as to what extent light sensitivity plays in the condition experienced by the different ethnic groups.  Clinicians^7,42 informed us that a few thousand people with lupus in the UK could be affected by low energy lighting.  Lupus UK informed us that, in their opinion, around 10,000 people with lupus in the UK could potentially be affected by low energy lighting, but the number is undetermined.  Most lupus patients react to sunlight (60-80%) in some way and to varying degrees.

Xeroderma Pigmentosum

Clinicians ^6,7 and the XP Support Group⁸ suggest that there are around 45 to 100 cases of XP in the UK, with early onset in children.  This is a genetic disease with sensitivity to UV light.  XP has been reported in people of every ethnic group all over the world.

Cognetial erythropoietic porphyria (CEP)

CEP is a very rare condition, with about 40 patients in the UK⁷.  People with CEP have severe and disfiguring reactions to sun and artificial light.  SCENIHR² noted that the prevalence of congential erythropoietic porphyria (Gunther’s disease) in the UK is approximately 2 per 3,000,000.

Solar urticaria

This is an abnormal reaction to sunlight and artificial light, affecting both sexes and may occur at any time of life.  The prevalence of idiopathic SU in Tayside, Scotland was estimated at 3.1 per 100,000⁹ (Beattie et al 2003).  The most common provoking wavelengths are longer UVA and shorter visible.  The mean age of onset was found to be 41 years.  People with this condition can also be affected by transmission of the light radiation through glass.

Polymorphic light eruption (PLE)

PLE affects ten to twenty percent of the northern european population, is more common in females than males and affects all ethnic groups.  Those suffering from PLE can arise from as little as 20 minutes exposure to the sun, including through window glass, and in some cases from fluorescent lighting.  PLE usually do so before the age of 30 years.  Both long (UVA) and short (UVB) wavelengths of UV light can cause PLE\in a susceptible person¹⁰.

Chronic actinic dermatitis

Skin becomes inflamed in areas exposed to sunlight or artificial\light, and the majority of sufferers have an allergy of some kind.  CAD is most prevalent in men over 50 years of age.  It also affects women and is increasingly found in young male and female patients with atopic eczema.  CAD patients are particularly affected by long wavelength UV and visible light wavelengths.  They are advised to avoid direct exposure to fluorescent and metal halide lights¹¹.

Actinic prurigo

Evidence on this condition was reviewed by SCENIHR².  This is an uncommon condition that particularly affects American Indians and less frequently Caucasian and Asian populations.  Age on onset is usually before 10 years and it predominantly affects females.  Its prevalence is estimated at 3.3 per 100,000 of the general population.

Fluorescent light immediate photosensitivity syndrome

Dr Sarkany (St Thomas’ Hospital⁷) informed us of patients with this condition.  The numbers affected are unknown.

Autistic spectrum disorders (ASD)

The prevalence is ASD is given as 1 in 167 (ref 12).  The National Autistic Society informed us that from the 500,000 people in the UK estimated to have ASD, around 120,00 could be affected by light sensitivity in some form, but this has not yet been subjected to rigorous research.  We have seen references to several papers relating to the effects of fluorescent light on autistic patients ^13,1485, however further literature searches and assessment of the science would be useful.  A study in 2066¹⁵ indicated that as many as 1/100 children may have an ASD, which is four times as common in boys as girls.  The prevalence of childhood ASD is around 116 per 10,000.

Epilepsy

In March 2008 the National Society of Epilepsy indicated that they had not received reports of seizures resulting from new generation CFLs (which operate at high frequency) but some members had expressed anecdotal concern.  The NSE cite the prevalence of epilepsy at around five to ten cases per thousand people¹⁶.  Another study ¹⁷ quotes the prevalence at 7.5 per thousand.  Around five precent of epilepsy patients are thought to have photosensitive epilepsy.  One study¹⁸ indicates that around three precent of epilepsy patients are sensitive to flicker up to 110 Hz.  Epilepsy affects all ages and both sexes, though photosensitive epilepsy is twice as common in females as in males¹⁹.  There are differences in treatment regimes for men and women.  A study by Kobau et al²⁰ in the USA found no significant differences in prevalence by sex or ethnicity.  A website survey by Epilepsy Action^19,21 indicated that 7/174 responders (4%) thought their seizure had been caused by a CFL.  Three reported seizures due to a 2-D low energy bulb.  One respondent out of 174 reported a seizure due to an incandescent light bulb.

Migraine

A study by Becker et al (2008) found a prevalence of migraine at 14% in European countries, around 2.5 times higher in women than men.  Migraine can occur at all ages²³.  An American study²⁴ found the prevalence highest in the 35 to 45 age group and more common in low income groups.  A study by Lipton et al 2001²⁵ found migraine was more common in white people than black people.  The number affected by low energy lighting is unknown.

Chronic fatigue syndrome/myalgic encephalopathy (CFS/ME)

One clinician²⁶ indicated a prevalence of 1 in 250 people.  The ME association indicate from their website²⁷ that around 250,000 people in Britain have CFS/ME, of all ages.  People with CFS/ME may find the brightness or intensity of light affects them and also its quality.  SCENIHR² noted that according to self-reporting, about 52,500 people in the UK (=21% of myalgic encephalomyelitis) have increased sensitivity to light⁶¹.  It is not known how many with CGS/ME may be affected by CFLs or other specific low energy bulbs.

Ménieères disease

NHS choices website²⁸ indicates that approximately one in a thousand people develop Ménières disease and through it can occur at any age it is rare in children.  The Ménières Society²⁹ indicates an incidence of one in 2000, affecting both sexes equally and all ages, though most frequently between the ages of 20 and 50 years.  They indicate that Ménières disease affects mainly white people.  Further information would be required to establish whether low energy lighting is an aggravating factor.

Fibromyalgia

From the orphante website³⁰ fibromyalgia affects two to five percent of the population, and is four times as common in women as in men.  Onset is usually between 30 and 50 years of age.  To our knowledge the effect of low energy lighting on fibromyalgia has not been investigated.

Irlen-Meares syndrome

A review³¹ states that around 12 to 14 percent of the population suffers from Irlen syndrome, rising to 46% of those with dyslexia, attention deficit disorders and learn difficulties.  Bright lights or fluorescent lights are described as often making the situation worse.  Coloured overlays and lenses can be a remedial intervention in some cases.  We have not come across information specifically on low energy lighting and Irlen-Meares syndrome.

Dyspraxia

Statistically, there is likely to be one child with dyspraxia in every class of 20-30 children.  Dyspraxia affects more boys than girls³².  The effect of low energy lighting has not to the Department for Health’s knowledge been investigated.

HIV/AIDS

It is estimated that over 730,000 people have HIV in the UK³³.  SCENIHR² concluded that no risk from flicker concerning other symptoms than retinal diseases has been found for HIV-positive persons.

Consultation that has taken place with each equality target group externally or internally:

Issues surrounding the potential for there to be negative impacts associated by the use of energy-efficient lighting, as a result of EU measures to phase out incandescent lamps (as well as UK action with retailers and energy suppliers to phase out incandescent lamps on a voluntary basis in advance) were noted in 2007 by patient support groups and individual members of the public.  Early discussions were held with representatives from these groups in summer 2007 to assess the scale and extent of the problem, though at this stage there was an absence of scientific evidence that allowed the Government to properly assess the scale and extent of the problem.  Discussions with the Department for Health and Health Protection Agency began in autumn 2007.

The Government has maintained engagement with support groups, including Right to Light, SPECTRUM and Lupus UK by:

·      By receiving comments on the Governments analysis, targets and standards for domestic lighting via public consultation between December 2007 and March 2008 and, as part of this process, in person in January 2008.  Comments and feedback were published in July 2008.

·      Close engagement at official and Ministerial level with the All Party Parliamentary Group on Lupus, which held specific discussions (not limited to lupus) three times during 2008, including officials and Ministers from both Defra and the Department of Health as well as photo-dermatology specialists.

·      Specific meetings with DoH and HPA held at the UK’s Lighting Association in the summer of 2008.

·      Informal consultation on the proposed EU Regulation three times, in March 2008, October and November 2008 in order to inform the UK’s negotiation position.  In addition to this, patient support groups fed directly to the Commission’s stakeholder consultation processes throughout, in particular the Stakeholder Forum in October 2007, in Brussels.

This engagement has throughout the period of negotiation with the European Commission allowed the UK to develop a firm line that the phase out of incandescent lighting

List of consultees and research material was obtained:

HPA conducted preliminary research³⁴ into the emissions from CFLs.  HPA found that some CFLs (the open type) could, under close situations such as desk lighting, emit UV light at levels to give exposures above international Guidelines, whereas UV emissions from double envelope CFLs were very low.  The international guidelines were established by the International Commission on Non-ionising Radiation Protection (ICNIRP)³⁵.  The HPA also detected a degree of flicker in CFLs.

The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) reviewed relevant scientific work on light sensitivity.  Some support groups including SPECTRUM³⁶, submitted information in the course of preparatory work for the EuP directive 2005/32/EC domestic lighting Lot 19.  This was also given to SCENIHR.  SCENIHR published their Opinion on light sensitivity on 23 September 2008².

SCENIHR concluded that they “did not find suitable direct scientific data on the relationship between energy saving lamps and the symptoms in patients with various conditions (i.e. xeroderma pigmentosum, lupus, migraine, epilepsy, myalgic encephalomyelitis, Irlen-Meares syndrome, fibromyalgia, electrosensitivity, AIDS/HIV, hdyspraxia, and autism).  Therefore, SCENIHR examined whether three lamp characteristics (flicker, electromagnetic fields, and UV/blue light emission) could act as triggers for disease symptoms.  Due to lack of data on CFLs, existing data on traditional fluorescent tubes were extrapolated to situations when compact fluorescent lamps may be used.

While for some conditions either flicker and/or UV/blue light could exacerbate symptoms, there is no reliable evidence that the use of fluorescent tubes was a significant contributor.  Of all compact fluorescent lamps properties, only UV/blue light radiation was identified as a potential risk factor for the aggravation of the light-sensitive symptoms in some patients with such diseases as chronic actinic dermatitis and solar urticaria.”

SCENIHR reviewed the available scientific literature for each clinical condition potentially affected by low energy lighting.

The DoH has also engaged clinical experts, scientists and support groups throughout this process concerning the conditions described.  Information on these conditions is summarised below:

Lupus

SCENIHR’s observations were that some patients do describe artificial light causing problems.  Provoking wavelengths seem to be predominantly in the UVB dextending into UVA2.  A range of skin presentations include butterfly rash, a polymorphic light eruption presentation and lupus erythematosus tumidus are examples.  SCENIHR concluded that “Though their UV component, chronic exposure to CFL could possibly be a problem.  Systemic lupus is an important condition in that skin flares can be associated with internal disease activity.”

Our own investigations indicate that there is fairly strong evidence from the scientific literature that non-incandescent sources of lighting can aggravate symptoms of people with certain skin conditions, for example in one study³⁷ thirteen out of thirty photosensitive systemic lupus erythematosus patients described increases in disease activity following exposure to unshielded fluorescent lamps.  However standard acrylic diffusers appeared to afford protection.  It is known that ultraviolet UVA and UVB radiation can provoke skin rashes and other symptoms seen in lupus patients³⁸.

Xeroderma pigmentosum

SCENIHR commented that in XP’s classical excision repair defective form, there is a marked photosensitivity to UVB wavelengths.  Childhood development of skin cancer makes photoprotection against these wavelengths a priority.  SCENIHR concluded that “It is possible that unfiltered CFL could be associated with increased disease activity.  Patients are currently advised t avoid unfiltered fluorescent lighting.  There could be assumed to be a similar problem with other members of the group (of genophotodermatoses)”.

Information we have is from UK clinicians and the XP support group^6,7,8.  The sensitivity is so great, and the long term consequences (fatal cancers) of even very tiny amounts of UV, especially UVB, are so severe that XP patients are generally careful about fluorescent lights as well as the more obvious threat from daylight.

Porphyrias

Erythropoietic protoporphyria develops in childhood, or even during infancy.  SCENIHR noted that cutaneous porphyrias are particularly sensitive to the blue light region so there would be a theoretical argument when comparing tungsten bulbs (which have less blue light).  Porphyrias are rare disorders.  SCENIHR concluded that “CFL in extremely sensitive patients could possibly produce a slight increase in gthe problem compared to tungsten light sources, although there is published evidence against this³⁹”.  A clinician we contacted⁷ indicated that congential erythropoietic porphyria patients have symptoms from wavelengths between 400 and 420nm.

Solar urticaria

Solar urticaria wavelength dependency is most commonly in the UVAion extending into the visible and occasionally also affecting the UVB region.  SCENIHR concluded that “It is possible that some patients could be at risk from CFL.  It should be noted that incandescent light sources also cause problems in some patients”.

Polymorphic light eruption (PLE)

SCENIHR noted that Polymorphic light eruption is thought to be a delayed hypersensitivity response to cutaneous neo-antigens induced in susceptible individuals by UVA and UVB sunlight containing exposure. It may be provoked by exposure to high output artificial sources.  Characterisation of the effect of UV emissions on patients with polymorphic light eruptions has been undertaken⁴⁰.SCENIHR concluded that "It is possible that in the most severely affected, CFL could produce the eruption."

Chronic actinic dermatitis (CAD)

SCENIHR concluded that "the degree of photosensitivity suggests there may be a problem with CFL⁴¹ (Moseley 2008)". Professor Moseley also indicated to us that his group has been assessing the impact of CFLs on patients with light sensitivity and found that there may be effects on skin at close quarters with the open type of CFL. Other clinicians^7,42 have also indicated that patients with CAD are very sensitive to UV light (UVB, sometimes also UVA).

Fluorescent light immediate photosensitivity syndrome

Dr Sarkany (St Thomas' Hospital⁷) informed us of patients with this condition. These patients have problems with fluorescent and halogen lights but generally not with incandescent light sources. The commonest reaction is for redness and severe burning and prickling feelings in the skin within seconds to minutes of exposure. The numbers affected are unknown.

Actinic prurigo

SCENIHR concluded that severe cases may potentially be at risk from CFL.

Drug/chemical induced photosensitivity

Many drugs are recognised as capable of inducing photosensitivity. SCENIHR indicated that given the degree of photosensitivity, it is not anticipated that drug induced photosensitivity to the above will be a particular problem for the use of Amiodarone , Phenothiazine, Fluoroquinolone Antibiotics when patients are exposed to CFL compared with incandescent sources. For patients on Photofrin and other Anti-cancer Agents, potent intentional visible wavelength dependent photosensitisers, photosensitivity might be expected to arise with CFL to a greater extent than that seen currently with incandescent light sources because of the greater amount of blue light. However SCENIHR state that these patients are closely managed because of their known temporary phototoxicity, and so in practice this is not likely to constitute a significant problem.

Autistic spectrum disorders (ASD)

SCENIHR concluded that "There is no evidence showing negative effects of fluorescence light on autistic behavior, however, an influence cannot be excluded." SCENIHR noted that the studies of Colman et al. (1976)¹³, which suggested that repetitive behavior can be aggravated by the flickering nature of fluorescent illumination, had interpretative problems and could not be replicated (Turner 1999⁴³). However, a putative relationship between autism and migraine is still suggested by similarities between the two conditions, including the presence of sensory over-stimulation (Casanova 2008⁴⁴). We have also noted a paper by Gluskin¹⁴ which attempts to explain fluorescent light sensitivity of some people with autism. The National Autistic Society⁴⁵ informed us that flicker, wavelength and hum from lighting can aggravate ASD. A paper by Ludlow⁸⁴ et al indicated that abnormalities of colour perception in children with autistic spectrum disorders have been reported anecdotally. These authors investigated the use of coloured overlays for reading and found that these helped children with autistic spectrum conditions to read more quickly. Another study⁸⁵ supported the theory that autistic children engage in a significantly greater frequency of stereotypical behaviour under fluorescent as compared to incandescent lighting, however the numbers of children in the study were small.

Epilepsy

SCENIHR noted that while photosensitivity of epileptics is scientifically proven, it has not been analyzed if the flicker frequency range above 120 Hz causes seizures, as do frequencies of 15Hz to 18 Hz. SCENIHR concluded that "Seizures are induced by flicker but can be accurately correlated to the frequency only for a small range (3 Hz, 15 to 18 Hz). There is no scientific evidence that fluorescent lamps including CFL induce seizures." We have contacted several clinicians on this issue. Professor Harding¹⁹ indicated that between ten and twenty percent of patients have seizures provoked by artificial light of some sort, including discos, fluorescent lighting in supermarkets and lighting in the walls of underpasses. Professor Harding indicated that, regarding low energy lighting, it is difficult to provide accurate information except by surveys, such as the one carried out by Epilepsy Action, where 4% of the 174 responders thought their seizure had been caused by a CFL. We also note the research by the HPA³⁴ which detected a degree of flicker in CFLs (100Hz envelope with a modulation in excess of 15%).

Professor Wilkins⁴⁶ informed us that the highest frequency at which flicker can be perceived (critical flicker fusion threshold) is individual and influenced by age and attention, by brightness, modulation depth, field size etc. The highest frequency at which an individual perceives flicker (typically about 70-90Hz) predicts that individual's susceptibility to discomfort from flicker, including flicker at higher, imperceptible, frequencies such as flicker from fluorescent lighting.  100Hz flicker that is imperceptible because it is of too high a frequency or of too Iowa modulation can nevertheless:-be resolved by the human retina⁴⁷, and disturb the control of eye movements⁴⁸. Professor Wilkins indicated that if some people can actually see flicker from compact fluorescent lamps they are unlikely to tolerate it and it is likely to be a health hazard.

He had come across second hand reports of "seizure-like" feelings attributed to compact fluorescent lamps. He had been unable to track these down. The upper frequency limit for a photoparoxysmal EEG response to intermittent light is probably 70-80Hz, though sensitivity above 60Hz is rare. Intermittent photic stimulation during the EEG examination uses only brief bursts of stimulation. It is not known whether long-term exposure to higher frequencies increases the risk of seizures, as it does of headache. He has encountered anecdotal reports of seizures from 100Hz fluorescent lighting, although EEG studies would indicate that seizures are unlikely unless the lamps malfunction⁴⁹.

Migraine

SCENIHR noted that fluorescent lamps can cause eye-strain and headache (Wilkins et al 1991⁵⁰). Patients with migraine show somewhat lowered flicker fusion thresholds during migraine-free periods (Kowacs et al. 2004⁵¹). In addition, photophobia, which is an abnormal perceptual sensitivity to light experienced by most patients with headache during and also between attacks, is documented in many studies (Main et al. 2000⁵²).

People with migraine claim to be particularly sensitive to blue light (European Lamp Companies Federation). SCENIHR concluded that "Migraine can be induced by flicker in general (up to about 50 Hz) and patients are light sensitive during and between attacks. Scientific support for aggravating symptoms by flicker from fluorescent tubes was not found. There is anecdotal evidence of problems with blue light."

We contacted several clinical experts regarding the effect of low energy lighting on migraine.  One, Or Steiner⁵³ indicated that, amongst the patients he sees, complaints about old style fluorescent lighting are much less common than 20 years ago. He felt that claims relating to CFLs are equally unsupported and are rather less likely to be true in any significant number of cases since CFLs are much less associated with flicker than old style fluorescent lights. He did not feel that there is a significant public health issue arising from CFLs as a possible trigger of migraine. However, if the onus of proof lies with those who argue CFLs are safe, there may be a problem since the claims are difficult to disprove objectively as they are to prove.

Another expert, Professor Wilkins⁴⁶ indicated that 100 Hz flicker can affect visual search performance⁵⁴, cause somatic changes⁵⁵, including headache⁵⁶. He commented that there are large differences in fluorescent lamps due to the nature of the phosphor coating, and overall modulation can vary between 100% and about 30%⁵⁷. The halophosphate coating often exhibits persistence, retaining light from one discharge to the next. The more recent and more efficient phosphors, such as those used in CFLs, exhibit less persistence so the modulation depth is potentially greater. Regarding halogen lamps, Professor Wilkins commented that these have been associated with complaints of glare and some' of his migraine patients find them uncomfortable, possibly due to multiple high brightness sources in the field of view.

Ménières disease

Ménières’s disease is a disorder of the inner ear. Although the cause is unknown, it probably results from an abnormality in the fluids of the inner ear. Ménières’s disease is one of the most common causes of dizziness originating in the inner ear. SCENIHR's conclusion was "Light conditions are not associated with Ménières’s disease. However, the attacks may be aggravated by flicker."

One expert on Ménières disease we contacted, Professor Yardley⁵⁸ indicated that there are reports that certain kinds of lighting make dizziness worse, these are not hard evidence and it is hard to know what kinds of lighting cause the worst problems, but certainly any lighting that flickers of flashes could be a problem. In a survey carried out for the Ménières Society⁵⁹ lighting was cited as a problem for Ménières sufferers in 31% of respondents (10/32 patients), though this was not analysed according to lighting type.

Another clinical expert, Mr Peter Rea⁶⁰ indicated that many patients with balance disorders find bright lights as seen in supermarkets uncomfortable, and flickering lights. Flicker is particularly a problem for those with "visual preference", where the eyes effectively take over the part of the balance function lost by the ears. However Mr Rea is unaware of any research looking at different types of lighting for those with Ménières disease, and there is a lack of information to suggest this relates to low energy lighting.

Chronic' fatigue syndrome/myalgic encephalopathy (CFS/ME)

SCENIHR noted that chronic fatigue syndrome is one of several names given to a potentially debilitating disorder characterized by profound fatigue which lasts for at least six months.

People with chronic fatigue syndrome most often function at a substantially lower level of activity than they were capable of before the onset of illness. Patients report various nonspecific symptoms, including weakness, muscle pain, impaired memoryand/or mental concentration, insomnia, and post-exertional fatigue.

SCENIHR concluded that “There is conflicting evidence regarding patients' sensitivity towards light."

One clinician, Professor Pinching²⁶, indicated that the consistency of the stories about the adverse experiences of some CFS/ME patients with fluorescent strip lighting is enough to say there is a definite question to answer, but does not know the extent this relates to new low energy lighting. It is probably related to the distorted sensory processing that is a common part of the neurological effect of CFS/ME. Professor Pinching indicated that the issue is not just about the intensity of the light, but about the quality.

Another clinician Dr Maurice Murphy⁶² did not know of any evidence that demonstrates that CFLs or any other lighting has any effect, detrimental or otherwise, on CFS/ME. Some patients do indicate light sensitivity, but this could be part of a general hypersensitivity to various stimuli.  Dr Murphy thought there may be a maladaptive response, for example patients confining themselves indoors then finding it difficult to adapt to brighter lighting. Proper evidence would require a controlled study but this would be difficult practically.

Professor White⁶³ indicated that he would be surprised if radiation from low energy lighting had a detrimental effect on patients with CFS/ME, but would not be surprised if open studies supported such a relationship. This is because, for some patients, the knowledge that they were being exposed to radiation reported anecdotally to cause harm would be enough to cause such a reaction. Dr White was not aware of any studies to test a reaction to CFLs.

Fibromyalgia

SCENIHR concluded that "Light conditions do not play a role in fibromyalgia. Problems with fluorescent lamps are not investigated but are very unlikely."

Irlen-Meares syndrome

Irlen-Meares is a learning disability that manifests itself primarily as a difficulty with reading and spelling which may be improved by use of coloured lens or overlays. The Irlen-Meares syndrome is also known as Meares-Irlen syndrome and closely linked to Scotopic Syndrome.  SCENIHR indicated that there is no consensus reached within the scientific community about its actual distinctiveness from other forms of dyslexia. SCENIHR noted that self-reporting suggests that fluorescence lighting in contrast to incandescent light aggravate the symptoms of dyslexia. Probably the main problems are caused by UV radiation and blue light, emitted by cool white tubes (Irlen method⁶⁴). SCENIHR concluded that "It is has been shown that dyslectics and Irlen-Meares patients tend to have difficulties detecting flicker. Therefore, flicker from fluorescent tubes should not be a problem. There are self-reported indications that the condition is aggravated by mainly UV and blue light."

Dyspraxia

SCENIHR concluded that "No evidence in the scientific literature is found regarding any influence of light conditions on dyspraxia."

Photophobia

SCENIHR noted that photophobia is eye discomfort in bright light, which occurs in many diseases including migraine. Photophobia is a symptom most often associated with pathological eye conditions such as cataracts, corneal damage, burns, infections, inflammation, injury, retinal detachment, etc. People with lighter-coloured eyes and albinism often suffer from photophobia.

SCENIHR concluded that "Any effect of flicker, blue light and fluorescent tubes has not been investigated, but cannot be ruled out."

UV radiation, snow blindness and cataract

SCENIHR concluded that "Fluorescent light does not cause snow-blindness or cataract. This holds true for CFl, provided that UVC and UVB radiations are adequately filtered out."

Skin cancer

SCENIHR noted that ultraviolet radiation is a major environmental risk factor for skin cancers.  Therefore, UV radiation from artificial illumination sources should be reduced to a minimum. The UVC and UVB radiations are especially effective in damaging DNA, and in causing gene mutations and cancerous transformation of cells. The HPA³⁴ showed that some commercially available CFl emit short wavelength UV radiation down to the UVC region (254 nm). SCENIHR noted that UVA exposure from fluorescent lamps for indoor illumination is still far lower than from the sun or artificial tanning lamps. A case-control study in a population with low sun exposure showed that melanoma risk was not associated with fluorescent lighting in the home or offices⁶⁶. SCENIHR concluded that "Fluorescent lamps do not contribute significantly to the melanoma risk and by analogy CFl will not. Fluorescent lamps, including CFl, are estimated to contribute insignificantly to UV doses effective in causing skin carcinomas."

HIV/AIDS

SCENIHR noted that HIV-positive persons with retinal damage have been shown in one study to have increased sensitivity to flickering light (Plummer et al. 1998⁶⁵). Problems with fluorescent tubes have not been reported. SCENIHR concluded that "No risk from flicker concerning other symptoms than retinal diseases has been found for HIV-positive persons."

Retinal diseases

SCENIHR noted that photochemical damage from blue light may induce several harmful effects to the retina mainly by the production of singlet oxygen .Therefore filters are recommended to protect lens and retina from blue light if the antioxidant defence mechanisms and the presence of melanin cannot protect against the damage. SCENIHR noted that HIV-positive patients may have retinal damage such as infectious retinopathies and noninfectious complications, which makes them more sensitive to blue light. SCENIHR concluded that "Blue light may be harmful to those with retinal diseases. There is also some evidence that prolonged exposure to blue light may reduce the colour sensitivity of the intact retina."

Physical properties

Electromagnetic fields

The limit of exposure to the general public from EMF is based on guidelines by the International Committee on Non Ionising Radiation Protection (ICNIRP, 1998⁶⁷). The science relating to EMFs is kept under review by the World Health organisation⁶⁸ and by SCENIHR⁶⁹, and by the Health Protection Agency⁷⁰.  Information was provided to us, although not peer reviewed, that the electromagnetic fields (EMF) emitted from CFl could potentially cause symptoms among persons that consider themselves sensitive to CFl⁷¹. Recent extensive reviews indicate that there is no connection between acute EMF exposure from Extremely low Frequency (ELF) and radiofrequency (RF) fields and perceived symptoms^72,73,74. The HPA has also reviewed information on electrosensitivity⁷⁵. There is, however, little information on long term effects.  SCENIHR noted that the literature on the kinds and strength of EMF that are emitted from CFL is sparse. Like other devices that are dependent on electricity for their functions, CFLs emit electric and magnetic fields in the ELF range (mainly 50 Hz in Europe). In addition, CFL, in contrast to the incandescent light bulbs, also emit in the high frequency range (30-60 kHz). In a Swiss study⁷⁶ eleven different energy saving lamps were investigated and compared with two types of ordinary incandescent light bulbs regarding EMF emissions. All measured EMF values were far below any limits set by guidelines of international organizations like ICNIRP.  SCENIHR concluded that "Although there is scarce literature in the area, it seems that the electromagnetic fields generated from CFL are not unique to these lamps, and also not strong in comparison with EMF from any other devices. It has never been conclusively and convincingly shown that there exist any connections between EMF and the symptoms that are reported by persons with so-called electromagnetic hypersensitivity, although their symptoms are real and in many cases very severe. Thus, based on current scientific knowledge, there do not seem to be any correlation between EMF from CFL, and symptoms and disease states."

Colour quality/rendering

An HPA study³⁴ showed that the emission of all the tested CFLs in the visible spectral range consisted of a few narrow peaks, with very low emission between them. The authors commented that such a low emission in wide parts of the visible spectrum may require an increase in CFL brightness to perform similar visual tasks compared with other light sources, including tungsten halogen lamps. Professor Wilkins⁴⁶ commented that the spectral power distribution of light from CFLs is very uneven, those CFLs with the most efficient television phosphors exhibit just a few peaks, which means that the rendering of surface colours by such lamps is correspondingly poor. Where colour rendering is an important part of visual processing, this could affect visual comfort. There has been little, if any, investigation of these issues.

Ultraviolet light emissions

An HPA study² concluded that the UV emissions from a significant percentage of tested CFLs with single envelopes may result in foreseeable overexposure of the skin when these light bulbs are used in close proximity, for example in desk lighting applications. The UV emissions of the tested lamps were not expected to present a realistic hazard to eyes due to aversion responses to bright sources. The HPA issued advice¹ to the general public that these single envelope lamps should not be used less than 30 centimetres or one foot away, however doubly encapsulated CFLs could be used instead.

Cesarini and Muel⁷⁷ tested halogen lamps with a quartz envelope on human volunteers. At 10cm from human skin a minimal erythema was induced in about 10 minutes on clear back skin.  At a working distance of 50cm erythema could be observed on the back of the hands after 8 hours consecutive working.

Bloom et al⁷⁸ studied a 12volt 50 watt quartz halogen lamp, measuring the pyrimidine dimer forming potential of the lamps relative to the sun for the purpose of estimating the DNA toxicity of the lamps. The authors estimated that the relative risk to keratinocyte DNA in human skin, due to UVB and UVC output at a distance of seven centimetres is between 27 and 400% of the noontime summer sun in Michigan.

Studies by the D'Agostini group^79-81 showed that UV from uncovered halogen sources was potentially hazardous by the effects on human peripheral blood Iymphocytes, and cell damage and carcinogenic effects in mice.

Most of the studies quoted above relating to potential health effects from halogen bulbs are at least ten years old. Improvements to lamp design and shielding may have been made since then. Further studies on emissions from commonly available contemporary halogen sources would be welcome.

Flicker

The HPA study² found that the optical output of all the tested CFLs was modulated at a frequency between 15kHz and 40kHz, representing the frequency of the electronic ballast. In addition, all the CFLs had a 100Hz envelope with modulation in excess of 15%. This degree of modulation at this frequency may be perceivable.

References

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What does the consultation indicate about the negative impact of the policy, strategy or project?

With regard to the general public, SCENIHR concluded that "In the case of light sources such as table lamps to which individuals may be in close proximity (around 20 cm or less) the exposure to UV radiation, if the use of such sources is prolonged, might approach but is not likely to exceed the workplace limit. Thus, for this particular use, there may be a health risk for the general public. The committee notes that the use of double envelope bulbs or similar technology for such lighting devices would remove this risk³⁴. In other use situations the risk is considered negligible. Compact fluorescent lamps could create a risk of blue light overexposure contributing to some retinal damage when in close proximity to the eye."

SCENIHR² concluded overall, given the current state of scientific knowledge, for non skin conditions that:

·      There is evidence showing that flicker can cause seizures in patients with photosensitive epilepsy, although there are no reported effects of CFL having such effects [Evidence level E].

·      Migraine can be induced by flicker, but no evidence has been provided that CFL induce migraine.

·      Blue light can aggravate retinal diseases in susceptible patients, or possibly aggravate migraine.

·      It cannot be excluded that Photophobia is induced or aggravated by different light conditions, but it is not mentioned in self-reports.

·      People with Autism/Aspergers syndrome have reported problems which they attributed to fluorescent lighting.

·      There is sufficient evidence that the conditions of patients with Irlen-Meares syndrome are not influenced by CFL. No reported effects indicate that symptoms in patients with ME, fibromyalgia, dyspraxia, and HIV would be aggravated by CFL.

·      It is unlikely that fluorescent lamps can cause snow-blindness or cataracts.

·      It is unlikely that any EMF emitted from CFL or other fluorescent lamps would contribute to electromagnetic hypersensitivity However, any possible health problems related to flicker and UV/blue light emission are minimized, if CFL are equipped with functional high-frequency electronic ballasts, double envelopes and adequate coating.

SCENIHR concluded for skin conditions that:

·      There is sufficient evidence to show that UV and in some cases visible radiation from lamps can provoke a clinically significant skin reaction in light-sensitive patients.

·      Fluorescent lamps, including CFL emit UV radiation that may be harmful to a sub-set of particularly sensitive patients.

·      CFL may be harmful when in close proximity to the skin (around 20 cm or less).

Overall SCENIHR concluded that "Of all CFL properties, only UV/blue light radiation was identified as a potential risk factor for the aggravation of the light-sensitive symptoms in some patients with such diseases as chronic actinic dermatitis and solar urticaria. No evidence was found that would indicate that either EMF or flicker could be a significant contributor" and "That the use of double-envelope energy saving bulbs or similar technology would largely or entirely mitigate both the risk of approaching workplace limits on VV emissions in extreme conditions and the risk of aggravating the symptoms of light-sensitive individuals. "

SCENIHR's preliminary rough estimation of the worst-case scenario yields a number of around 250,000 light sensitive individuals (0.05% of the population) in the EU, which equates to about 30,000 in the UK given a population of 60 million.

We note that SCENIHR identified that UV/blue light radiation was a potential risk factor for the aggravation of the light-sensitive symptoms in some patients. The Government's opinion has been that UV emissions should be considered in setting standards for CFLs, halogen lamps and indeed for all light bulbs where appropriate allowed onto the market under the EuP Directive and this has been included in the proposed Regulation. We would encourage that the maximum emissions for UV allowed should not be set such that they could lead to exposures above ICNIRP guidance levels. ICNIRP set guidelines for blue light emissions in 1997⁸². The possibility of technical criteria relating to blue light emissions could be investigated further should further information become available.

It is recognised that there is little or no medical evidence on adverse health effects of flicker from low energy lighting; however, a number of research studies indicated that flicker from fluorescent lighting may cause eyestrain, fatigue, affect visual performance, at some frequencies potentially cause seizures in epileptic patients, and aggravate repetitive behaviour in autistic patients. The physiological and health implications of flickering light needs further research.

Mercury: CFLs contain a very small amount of mercury, the typical amount is under 4 milligrams per lamp. HPA advice⁸³ is that the mercury cannot escape from an intact lamp and, even if the lamp should be broken, the very small amount of mercury contained in a single, modern CFL is most unlikely to cause any harm. However it makes sense to avoid unnecessary contact with mercury; and a broken light bulb will also produce sharp pieces of glass. HPA give advice on safe disposal methods.

Changes that have been made to the policy as a result of research and/or consultation:

The policy proposals are made at a European level and voted on via comitology, as set out in the Framework Directive for the Eco-design of Energy-using Products (2005/32/EC). The UK has, in light of the engagement with specialists, clinicians, scientists, and patient support groups, been very pro-active in raising this issue at EU level from the very early stages of negotiation, and has been the only Member State to do so. In light of this pressure, the Commission's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was tasked to assess the issue in more detail in order for the Commission's proposed Regulation to be fully evidence-based.

The UK has consistently pressed for the most ambitious measures to make the greatest energy savings but which will avoid unintended impacts. In light of the evidence presented above, the Government recognises the need for halogen lamps to remain on the market in order to mitigate the scale of the problems associated with the use of energy-efficient lighting.

In making its final proposals, the European Commission stated in November 2008: "From the point of view of energy-efficiency alone, it is clear that the aim would be to go for a minimum requirement for energy class '~" as soon as possible, which would only leave compact fluorescent lamps and LEDs on the market. However, Article 15 paragraph 5 of the Ecodesign Directive (2005/32/EC) requires the Commission to also look into other aspects than the environmental improvement potential before adopting ecodesign implementing measure, in particular that: '(a) there shall be no significant negative impact on the functionality of the product, from the perspective of the user; (b) health, safety and the environment shall not be adversely affected; (c) there shall be no significant negative impact on consumers in particular as regards the affordability and the life-cycle cost of the product; (d) there shall be no significant negative impact on industry's competitiveness.' Taking into account these aspects, there should be alternatives to CFLs and LEDs on the market, and the phasing out of incandescent lamps should be carefully scheduled. Details are provided in the accompanying Explanatory memorandum and in the draft regulation itself."

The UK has also consistently pressed for ambitious 'functionality requirements' to be set on lamps as part of the Regulation and the draft Regulation proposes minimum standards for UV emissions, as referred to above. This is primarily to protect the public at large from over exposure to UV light, but will help limit the UV light that those with photo-sensitive conditions will be exposed to.

Policy review:

The European Commission will assess the policy 5 years after entry into force (i.e. circa 2014).