OPINION OF ADVOCATE GENERAL
SHARPSTON
delivered on 6 April 2017(1)
Case C‑531/15
Elda Otero Ramos
v
Servicio Galego de Saúde
and
Instituto Nacional de la Seguridad Social
(Request for a preliminary ruling from the Tribunal Superior de Justicia de Galicia (High Court of Justice of Galicia, Spain))
(Social policy – Directive 2006/54/EC – Equal treatment of male and female workers – Article 19 – Rules reversing the burden of proof – Directive 92/85/EEC – Article 4 – Assessment for activities liable to involve exposure to agents, processes or working conditions)
1.        By this request for a preliminary ruling the referring court, the Tribunal Superior de Justicia de Galicia (High Court of Justice of Galicia, Spain), seeks guidance on the interpretation of the rules which place the burden of proof on the respondent in cases where the applicant claims that the principle of equal treatment has not been applied to them on grounds of sex. That reversal of the burden of proof derives from Directive 2006/54/EC on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation. (2) The main proceedings concern a worker who claims that during the period she was breastfeeding her child, her working conditions were liable to adversely affect her health or that of her baby. Her claim was made pursuant to national rules which implement Directive 92/85/EEC on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding. (3) The questions posed by the referring court require this Court to give guidance as to how that directive should be read in conjunction with the rules in Directive 2006/54 on the burden of proof.
EU law
The Charter of Fundamental Rights of the European Union
2.        Article 23 of the Charter of Fundamental Rights of the European Union (4) states that equality between women and men must be ensured in all areas including employment, work and pay.
Directive 89/391
3.        Council Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work (5) defines ‘prevention’ as meaning ‘all the steps or measures taken or planned at all stages of work in the undertaking to prevent or reduce occupational risks’. (6) The directive states that particularly sensitive risk groups must be protected against the dangers which specifically affect them (7) and empowers the EU legislature to adopt individual directives to encourage improvement in the working environment as regards the health and safety of workers. (8)
Directive 92/85
4.        The objectives of Directive 92/85 include introducing minimum requirements for encouraging improvements, especially in the working environment, to protect the safety and health of workers. (9) Pregnant workers and workers who have recently given birth or who are breastfeeding are considered to be a specific risk group. (10) Such protection should not treat women on the labour market unfavourably nor work to the detriment of directives concerning equal treatment for men and women. (11) Certain types of activities may pose a specific risk of exposure to dangerous agents, processes or working conditions for workers who are breastfeeding. In relevant cases, those risks should be assessed and the result of the assessment communicated to female workers. (12) Where the assessment reveals the existence of a risk to the safety or health of a female worker, provision must be made for her protection. (13) Workers who are breastfeeding must not be required to engage in activities which have been assessed as revealing a risk of exposure to certain particularly dangerous agents or work in conditions that jeopardise their safety and health. (14)
5.        Article 1(1) states that the purpose of Directive 92/85 ‘which is the tenth individual Directive within the meaning of Article 16(1) of Directive [89/391], is to implement measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or who are breastfeeding’.
6.        A worker who is breastfeeding is defined in Article 2(c) as ‘a worker who is breastfeeding within the meaning of national legislation and/or national practice and who informs her employer of her condition, in accordance with that legislation and/or practice’. (15)
7.        As required by Article 3(1), the Commission has drawn up guidelines on the assessment of the chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of workers within the meaning of Article 2. (16)
8.        Article 4(1) states that for all activities liable to involve a specific risk of exposure to the agents, processes or working conditions listed non-exhaustively in Annex I, (17) the employer shall assess the nature, degree and duration of exposure, in the undertaking and/or establishment concerned of workers within the meaning of Article 2. The assessment is made in order to assess any risks to the safety or health and any possible effect on, inter alia, the breastfeeding of the worker concerned, and to decide what measures should be taken. Pursuant to Article 4(2), the worker concerned must be informed of the results of that assessment and of all measures to be taken concerning health and safety at work. The guidelines serve as the basis for that assessment.
9.        Article 5 is entitled ‘Action further to the results of the assessment’. It states:
‘1.      Without prejudice to Article 6 of Directive [89/391], if the results of the assessment referred to in Article 4 (1) reveal a risk to the safety or health or an effect on the pregnancy or breastfeeding of a worker within the meaning of Article 2, the employer shall take the necessary measures to ensure that, by temporarily adjusting the working conditions and/or the working hours of the worker concerned, the exposure of that worker to such risks is avoided.
2.      If the adjustment of her working conditions and/or working hours is not technically and/or objectively feasible, or cannot reasonably be required on duly substantiated grounds, the employer shall take the necessary measures to move the worker concerned to another job.
3.      If moving her to another job is not technically and/or objectively feasible or cannot reasonably be required on duly substantiated grounds, the worker concerned shall be granted leave in accordance with national legislation and/or national practice for the whole of the period necessary to protect her safety or health.
…’
10.      The first paragraph of Article 11 reads as follows:
‘In order to guarantee within the meaning of Article 2 the exercise of their health and safety protection rights as recognised in this Article, it shall be provided that:
1.      In the cases referred to in [Article 5] the employment rights relating to the employment contract, including the maintenance of a payment to, and/or entitlement to an adequate allowance for, workers within the meaning of Article 2, must be ensured in accordance with national legislation and/or national practice;
…’
Directive 2006/54
11.      The recitals to Directive 2006/54 state, first, that Council Directive 97/80/EC (18) laid down provisions which aimed, inter alia, to implement the principle of equal treatment between men and women. (19) Second, it is clear from the Court’s rulings that unfavourable treatment of a woman related to pregnancy or maternity constitutes direct discrimination on grounds of sex. Such treatment should therefore be expressly covered by Directive 2006/54. (20) Third, the Court has consistently recognised the legitimacy, as regards the principle of equal treatment, of protecting a woman’s biological condition during pregnancy and maternity and of introducing maternity protection measures as a means to achieve substantive equality. Directive 2006/54 should therefore be without prejudice to Directive 92/85. (21) The aims of Directive 2006/54 thus include protecting employment rights for women on maternity leave, to ensure that they do not suffer detriment in their terms and conditions as a result of taking such leave and that they benefit from any improvement in their working conditions to which they would have been entitled during their absence. (22)
12.      Fourth, the recitals recognise that ‘the adoption of rules on the burden of proof plays a significant role in ensuring that the principle of equal treatment can be effectively enforced. As the Court of Justice has held, provision should therefore be made to ensure that the burden of proof shifts to the respondent when there is a prima facie case of discrimination, except in relation to proceedings in which it is for the court or other competent national body to investigate the facts. It is however necessary to clarify that the appreciation of the facts from which it may be presumed that there has been direct or indirect discrimination remains a matter for the relevant national body in accordance with national law or practice. Further, it is for the Member States to introduce, at any appropriate stage of the proceedings, rules of evidence which are more favourable to plaintiffs’. (23)
13.      Article 1 provides that the purpose of Directive 2006/54 is ‘to ensure the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation’.
14.      Direct discrimination is defined in Article 2(1)(a) as arising ‘where one person is treated less favourably on grounds of sex than another is, has been or would be treated in a comparable situation’. Indirect discrimination exists ‘where an apparently neutral provision, criterion or practice would put persons of one sex at a particular disadvantage compared with persons of the other sex, unless that provision, criterion or practice is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary’ (Article 2(1)(b)). For the purposes of Article 2(2)(c), ‘discrimination’ includes ‘any less favourable treatment of a woman related to pregnancy or maternity leave within the meaning of [Directive 92/85]’.
15.      Specific provisions including the prohibition of discrimination in matters of equal pay and equal treatment in occupational social security schemes are set out in Title II. Chapter 3 forms part of Title II and contains Article 14, which prohibits discrimination as regards access to employment, vocational training and employment and working conditions.
16.      Article 19, which forms part of Title III (‘Horizontal Provisions’), provides:
‘1.      Member States shall take such measures as are necessary, in accordance with their national judicial systems, to ensure that, when persons who consider themselves wronged because the principle of equal treatment has not been applied to them establish, before a court or other competent authority, facts from which it may be presumed that there has been direct or indirect discrimination, it shall be for the respondent to prove that there has been no breach of the principle of equal treatment.
2.      Paragraph 1 shall not prevent Member States from introducing rules of evidence which are more favourable to plaintiffs.
…
4.      Paragraphs [1 and 2] shall also apply to:
(a)      the situations covered …, in so far as discrimination based on sex is concerned, by [Directive 92/85] …
…’
17.      Pursuant to Article 28, Directive 2006/54 is to be without prejudice to (European Union and national) provisions concerning the protection of women, particularly as regards pregnancy and maternity. It is also specifically stated to be without prejudice to, inter alia, Directive 92/85.
Spanish legislation
18.      Under Article 26(1) of the Ley de Prevención de Riesgos Laborales (the Law on the Prevention of Occupational Risks) (‘the LPRL’), the risk assessment for, workers who are pregnant or who have recently given birth must involve a determination of the nature, degree and duration of exposure to agents, processes or working conditions liable to affect adversely the health of the worker or the foetus in any activity likely to present a specific risk. If the results of that assessment reveal a risk to safety or health or a possible effect on a pregnant or breastfeeding woman, the employer must adopt the measures necessary to avoid exposure to that risk by adjusting the working conditions and the working hours of the person concerned. Such measures shall if necessary include exempting them from night work or shift work.
19.      In accordance with Article 26(2) of that law, if, an adjustment of working conditions or working hours is not feasible or if, notwithstanding such adjustment, the working conditions would have a negative effect on the health of the pregnant worker or the foetus, she must perform different tasks that are compatible with her condition. Employers must establish, after consultation with the workers’ representatives, a list of jobs that are risk free. A transfer to such a job must be made where it is possible to do so. However, Article 26(3) provides that, if a move to another job is not technically or objectively feasible or cannot reasonably be required on substantiated grounds, the worker concerned may have her contract suspended on the grounds that she is at risk during pregnancy, for the period necessary to protect her safety and health and for as long as it remains impossible for her to return to her previous job or to another job that is compatible with her condition.
20.      Pursuant to Article 26(4) of that law, a worker who is breastfeeding her child comes within the scope of Articles 26(1) and (2) if her working conditions are liable to affect adversely her health or that of her child and a certificate to that effect is issued by the medical department of, inter alia, the Instituto Nacional de la Seguridad Social (National Institute for Social Security) (‘the INSS’), together with a report from the doctor of the Servicio Nacional de Salud (National Health Service) who treats the worker or her child. The worker concerned may likewise have her contract suspended under Article 26(3) on the grounds of risk while breastfeeding a child under nine months old if a transfer to another job is impossible in the circumstances of her case.
21.      Article 135 bis of the Ley General de la Seguridad Social (‘the General Law on Social Security) provides that, for the purposes of the financial allowance which is paid to a breastfeeding mother who is deemed to be at risk in her job (‘the financial allowance’), the period of suspension of her contract constitutes ‘a protected situation’ where it is not possible for her to move to another position in accordance with Article 26(4) of the LPRL.
22.      The referring court adds that the Ley Orgánica 3/2007, de 22 de marzo, para la igualdad efectiva de mujeres y hombres (Organic Law 3/2007 of 22 March on effective equality between women and men) introduced provisions governing the situation of mothers at risk during the period when they breastfeed their babies. Prior to that act the position had not been regulated by Spanish law; legislation was introduced in order to comply with Directive 92/85 and in particular Article 5(3) of that directive.
Facts, procedure and questions referred
23.      Ms Elda Otero Ramos is employed as a nurse in the accident and emergency department of the Centro Hospitalario Universitario de A Coruña (the University Hospital Centre, Corunna; ‘the hospital’), which is part of the Servicio Galego de Saúde (the Galician Health Service). On 22 December 2011 she gave birth to a daughter whom she breastfed.
24.      On 8 May 2012, Ms Otero Ramos requested a medical certificate from the INSS attesting that she fell within the definition of a worker who is breastfeeding her child within the meaning of the national rules and that carrying out her duties as a nurse in the accident and emergency department of the hospital placed her at risk. (24)
25.      The following information was considered in the assessment relating to Ms Otero Ramos’ request: first, a declaration by the director of human resources at the hospital stating that: (i) she was a nurse in the accident and emergency department; (ii) her working conditions involved shift work covering mornings, afternoons, evenings and the night-time period; (iii) the specific risk that arose in the case of a breastfeeding mother was identified in a report on preventive medicine attached to the declaration; and (iv) her post was ‘…classified as risk-free in the list of jobs drawn up by the employer after consultation with the workers’ representatives’; second, the report of the doctor in the department of preventive medicine for occupational risks (mentioned in (iii) above), which confirmed that Ms Otero Ramos had been assessed and that the medical report that she had provided had also been examined; the doctor declared her to be ‘fit’ ‘… to carry out the duties which form part of her job, there being no risk to breastfeeding’. (25)
26.      Two days later, by decision of 10 May 2012, the INSS rejected Ms Otero Ramos’ request on the ground that it had not been established that her working conditions adversely affected her health (or that of her child). Accordingly, she was told that it would not be appropriate to start the procedure for obtaining the financial allowance. (26)
27.      On 11 July 2012, Ms Otero Ramos challenged the decision of the INSS before the Juzgado de lo Social No 2, de A Coruña (Social Court No 2, Corunna). (27) Attached to her application was a letter signed by her line manager, a doctor and the director of the hospital’s accident and emergency department (‘the line manager’s report’). That letter stated that a nurse working in the hospital’s accident and emergency department who is a breastfeeding mother is in jeopardy of being exposed to physical, chemical, biological and psychosocial risks to the maintenance of lactation. The line manager’s report included the following details relating to biological agents. Nurses are exposed to, for example, cases of influenza A, bacterial infections, multi-resistant germs, HIV and hepatitis. Regarding physical agents, patients of all kinds come to the hospital’s accident and emergency department. The majority have significant mobility difficulties caused by age or acute or chronic disease. That places a physical and postural burden on nursing staff. The physical burden increases if patients are in a critical condition (patients in a coma, cardiac arrests and the terminally ill). In relation to chemical agents, there is exposure to all types of chemical treatment because all manner of diseases are dealt with in the accident and emergency department. There are psychosocial risks because staff are subject to a complex shift rotation system (shift work and night work). There is also the stress and the burden caused by dealing with fluctuating demand which can at times be high, without an established nurse-patient ratio. At times of high demand for treatment, workers must constantly adapt in order to carry out their tasks and organise their work. For workers who are breastfeeding shift work and night shifts alter the production of prolactin, which is responsible for milk production. Working irregular hours and working nights can cause mastitis due to alteration of the rate of milk extraction.
28.      On 24 October 2013 Ms Otero Ramos’ application was dismissed. The court at first instance ruled that according to national case-law, a strict criterion is to be applied as regards the assessment of evidence relating to whether a risk exists for the purposes of granting the financial allowance. Ms Otero Ramos appealed to the referring court, which wishes to ascertain whether her circumstances fall within the scope of Directive 2006/54. If that is the case it seeks guidance on how, in particular, Article 19 of that directive should be read in the light of the provisions of Directive 92/85. Accordingly the referring court requests a preliminary ruling on the following questions:
‘(1) Are the rules on the burden of proof laid down in Article 19 of Directive [2006/54] applicable to the situation of risk during breastfeeding referred to in Article 26(4), in conjunction with Article 26(3), of [the LPRL], which was adopted to transpose Article 5(3) of [Directive 92/85] into Spanish law?
(2) If Question 1 is answered in the affirmative, can the existence of risks to breastfeeding when working as a nurse in a hospital accident and emergency department, established by means of a report issued by a doctor who is also the director of the accident and emergency department of the hospital where the worker is employed, be considered to constitute facts from which it may be presumed that there has been direct or indirect discrimination within the meaning of Article 19 of [Directive 2006/54]?
(3) If Question 2 is answered in the affirmative, can the fact that the job performed by the worker is included in the list of risk-free jobs drawn up by the employer after consulting the workers’ representatives and the fact that the preventive medicine/prevention of occupational risks department of the hospital concerned has issued a declaration that the worker is fit for work, without those documents including any further information regarding how those conclusions were reached, be considered to prove, in every case and without possibility of challenge, that there has been no breach of the principle of equal treatment within the meaning of Article 19 of [Directive 2006/54]?
(4) If Question 2 is answered in the affirmative and Question 3 is answered in the negative, which of the parties — the applicant worker or the defendant employer — has, in accordance with Article 19 of [Directive 2006/54], the burden of proving, once it has been established that performance of the job creates risks to the mother or the breast-fed child, (1) that the adjustment of working conditions or working hours is not feasible or that, despite such adjustment, the working conditions are liable to have an adverse effect on the health of the pregnant worker or breast-fed child (Article 26(2), in conjunction with Article 26(4), of the [the LPRL], which transposes Article 5(2) of [Directive 92/85]), and (2) that it is not technically or objectively feasible to move the worker to another job or that such a move cannot reasonably be required on substantiated grounds (Article 26(3), in conjunction with Article 26(4), of [the LPRL] which transposes Article 5(3) of [Directive 92/85])?’
29.      Written observations have been submitted by Ms Otero Ramos, the INSS, the Spanish Government and the European Commission. At the hearing on 19 October 2016 the same parties, save for Ms Otero Ramos, presented oral argument.
Assessment
Preliminary remarks
30.      The objective of Directive 92/85, which was adopted on the basis of Article 118a of the EEC Treaty (the precursor of Article 153 TFEU), is to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or who are breastfeeding. (28) That directive is one of the measures adopted within the framework of Directive 89/391. (29) Directive 92/85 identifies, inter alia, breastfeeding mothers as a particularly sensitive risk group of workers which must be protected against the dangers that specifically affect them and for whom measures must be taken with regard to their health and safety. (30) That protection should not work to the detriment of directives concerning equal treatment for men and women. (31) Directive 2006/54 is one example of the latter type of measure.
31.      It is not in dispute that at the material time Ms Otero Ramos fell within the definition of a worker who is breastfeeding in Article 2(2)(c) of Directive 92/85 and that her employer was therefore required to carry out a risk assessment under Article 4(1) of that directive in accordance with the guidelines mentioned in Article 3(1) .
32.      All four questions posed by the referring court are linked in so far as they are based on the premiss that an assessment pursuant to Article 4(1) of Directive 92/85, if carried out correctly and on the basis of all the relevant evidence, might well reveal either a risk to Ms Otero Ramos’ health or safety or a potential effect on her condition as a breastfeeding mother. It follows from that premiss that the conditions for further action in Article 5 of Directive 92/85 would be met.
Question 1
General remarks
33.      By its first question the referring court seeks to ascertain whether the situation on which it has to adjudicate falls within the scope of Directive 2006/54. In particular, it wonders whether Ms Otero Ramos bears the burden of proof or whether that burden is reversed and the onus is placed upon the respondents.
34.      In the preliminary reference procedure, providing for cooperation between national courts and the Court, it is for the latter to provide the national court with an answer which will be of use and enable that court to determine the case at issue. To that end, the Court may have to reformulate the questions referred. Moreover, the Court has a duty to interpret all provisions of EU law which national courts require in order to decide the actions pending before them, even if those provisions are not expressly indicated in the questions referred to the Court. (32) Consequently, even though the referring court’s first question refers expressly only to Article 5(3) of Directive 92/85, that does not prevent this Court from providing the referring court with all the necessary elements of interpretation of EU law, including other provisions of that directive (here, in particular Article 4) that may be of assistance in adjudicating in the case pending before it, whether or not the referring court has referred to such provisions in the wording of its questions. It is, in this regard, for the Court to extract from all the information provided by the referring court, in particular from the reasoning of the decision to make the reference, the points of EU law which require interpretation in view of the subject-matter of the dispute. (33)
35.      The order for reference states that the INSS decided ‘not to issue the certificate requested because it ha[d] not been established that the conditions of the job the applicant perform[ed] adversely affect[ed] her health (or that of her child) …’ Yet Question 1 is based on the premiss that there was evidence pointing to the existence of such a risk. (34)
36.      Directive 92/85 introduced a requirement to evaluate and communicate risks. Where the results of the risk assessment carried out pursuant to Article 4(1) of that directive reveal a risk to safety or health and an effect on the pregnancy or breastfeeding of a worker, Article 5(1) and (2) provides that the employer is required temporarily to adjust the working conditions and/or the worker’s working hours. (35) If that is impossible in the circumstances, the worker concerned must be moved to another job. It is only when such a move is not feasible that Article 5(3) of that directive provides that the worker is to be granted leave, in accordance with national legislation and/or national practice, for the whole of the period necessary to protect her safety or health. (36)
37.      However, if the assessment carried out pursuant to Article 4(1) of Directive 92/85 does not reveal a risk, it follows from that provision read together with Article 5(1) of Directive 92/85 that the employer is then not required to take further action. It is evident from the order for reference that, precisely because the hospital’s risk assessment under Article 4 concluded that Ms Otero Ramos was not at risk, the condition in Article 5 for triggering consideration of whether Ms Otero Ramos’ working conditions should be adjusted, whether she should be moved to another job, or whether she should be granted leave has not yet been met.
38.      It is equally evident that Ms Otero Ramos disputes the hospital’s assessment and that she contests the decision of the INSS rejecting her application for the financial allowance. She considers that it is clear from the facts as recorded in the order for reference that her duties as a nurse in the hospital’s accident and emergency department did indeed place her at risk and that it would obviously have been impossible to reconcile being able to breastfeed her child with the requirements of her job.
39.      The first step in the procedure laid down by Directive 92/85 is to establish in accordance with Article 4, whether there is a risk to the health or safety of a worker covered by Article 2. Determining as to whether the assessment of Ms Otero Ramos’ position was correct will require consideration of questions of fact which fall to the referring court. However, the correct interpretation of the requirements of Article 4(1) of Directive 92/85 is a matter for this Court.
40.      Thus, Question 1 must be understood as seeking guidance: (i) on the interpretation of Article 4 of Directive 92/85; (ii) (where a decision based on an assessment under that provision is challenged by the worker concerned) as to whether the burden of proof is on the claimant or the respondent for the purposes of Article 19 of Directive 2006/54; and (iii) (if such a challenge is successful and a risk to the worker concerned is established) as to whether it then falls to the employer to determine the appropriate steps to take in accordance with Article 5 of Directive 92/85.
Directive 92/85
41.      It is common ground between the parties that it is necessary to determine whether the INSS’s decision that there was no risk to Ms Otero Ramos was founded upon a correct assessment of her circumstances.
42.      Pursuant to Article 4(1) of Directive 92/85, the employer must ‘assess the nature, degree and duration of exposure … of workers within the meaning of Article 2’ in respect of ‘all activities liable to involve a specific risk of exposure to the agents, processes or working conditions’ listed non-exhaustively in Annex I. That assessment is done in order to ‘assess any risks to the safety or health and any possible effect on the pregnancy’s (sic) or breastfeeding …’ and to ‘decide what measures should be taken’. (37)
43.      That wording should be read in conjunction with the guidelines referred to in Article 3(1) of Directive 92/85, which Article 3(2) states are ‘to serve as a basis for the assessment referred to in Article 4(1)’. Those guidelines make it abundantly clear that a broad brush, generic assessment of the workplace, the conditions surrounding particular jobs and the general state of health of the average female worker who is pregnant, has recently given birth or who wishes to breast-feed is unlikely to satisfy the requirements of Article 4(1).
44.      Thus, the guidelines emphasise that ‘some hazards in the workplace may affect the health and safely of new and expectant mothers and of their children’. They note that the qualitative and quantitative risk assessment ‘represents the most delicate phases in the process, in that the person carrying out the assessment must be competent and take due account of relevant information, including information from the pregnant woman herself or her advisors, in applying appropriate methods in order to be able to conclude whether or not the hazard identified entails a risk situation for workers’. (38) The risk assessment ‘must take into account the preventive aspects of [Directive 89/391]’. (39) The risk assessment ‘is of a special nature, as it is designed for a continually changing state which varies according to each individual. In addition, it does not affect only the woman herself, but also the unborn child and the breast-feeding baby. ... A one-off assessment may not be enough, as pregnancy is a dynamic process and not a static condition. Furthermore, not only during the various stages of a pregnancy but also after delivery, different risks can affect a woman and her unborn or new-born child to a varying extent … Medical advices, reports and certificates should take working conditions into consideration. This is of particular relevance to an individual’s conditions … Risk assessments should take due account of medical advice and the concerns of the individual woman’. (40) The guidelines emphasise that employers are required to keep the risks under review, pointing out that ‘there are different risks [from the risks during pregnancy itself] to consider for workers who have recently given birth or are breastfeeding. Employers need to ensure that workers who are breastfeeding are not exposed to risks that could damage health or safety for as long as they continue to breastfeed.’ (41)
45.      The guidelines also contain two detailed tables. The first is entitled ‘risk assessment of generic hazards and associated situations’, which ‘are likely to be met by most pregnant women, new/ or breastfeeding mothers’. (42) The second is entitled ‘Risk assessment: specific hazards (and ways of avoiding risks)’. Its introduction points out that ‘Since pregnancy is a dynamic state involving continuous changes and developments, the same working conditions may raise different health and safety issues for different women at different stages of pregnancy, and again on returning to work after childbirth or whilst breastfeeding. Some of these issues are predictable and apply generally … Others will depend on individual circumstances and personal medical history’. The table then examines in turn physical agents, biological agents, (43) chemical agents and working conditions. (44)
46.      The order for reference states that Ms Otero Ramos’s job was classified as ‘risk-free’ and that she was described as ‘fit’ for work. That seems to me to suggest that her employer’s approach may not fully have taken her individual circumstances into account. First, it is unclear whether the classification of her job as a nurse in the accident and emergency department as ‘risk-free’ established that that post was risk-free for pregnant workers or workers who have recently given birth or whether it took specifically into account the situation of breastfeeding mothers. (45) Second, there is no indication whether there was an assessment of the risks that Ms Otero Ramos herself might face when performing that job as a breastfeeding mother, such as the potential effects on lactation or whether there was a likelihood of mastitis or infection. Third, there is no information as to whether there was an assessment of her risk of exposure to the physical, biological and chemical agents listed in Annex I to Directive 92/85.
47.      Fourth, the hospital’s assessment effectively consists of a declaration that Ms Otero Ramos was ‘fit’ to carry out the duties which form part of her job, there being no risk to breastfeeding. I recall, however, that the assessment is a preventive measure and whose aim is to protect the breastfeeding mother; (46) and that the line manager’s report paints a rather different picture of the job of a nurse in the accident and emergency department (suggesting, for example, that workers may come into contact with patients infected with hepatitis). (47)
48.      It is for the referring court as sole judge of fact to verify whether the hospital’s assessment complied with Article 4(1) of Directive 92/85. If the referring court concludes that it did not, the next step is to consider whether Ms Otero Ramos’s claim falls within the scope of Directive 2006/54 and if so whether Article 19 of that directive applies. Furthermore, it is implicit from the order for reference that the referring court will also wish to consider whether Ms Otero Ramos could have been protected by measures taken pursuant to Article 5 of Directive 92/85.
Directive 2006/54
49.      The INSS and Spain submit that the present case does not fall within the scope of Directive 2006/54. Ms Otero Ramos and the Commission take the opposite view.
50.      I too disagree with the INSS and the Spanish Government’s restrictive interpretation of Directive 2006/54.
51.      The purpose of Directive 2006/54, in accordance with Article 1, is to ensure the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation.
52.      It is true that women actually taking maternity leave under Article 8 of Directive 92/85 ‘are in a special position which requires them to be afforded special protection, but which is not comparable either with that of a man or with that of a woman actually at work’. (48) However, it does not follow as the INSS and Spain seek to suggest, that all workers covered by Article 2 of Directive 92/85 fall outside the scope of Directive 2006/54.
53.      The concepts of direct and indirect discrimination are defined in respectively, Article 2(1)(a) and (b) of Directive 2006/54. Article 2(2)(c) provides that discrimination on grounds of sex includes ‘any less favourable treatment of a woman related to pregnancy or maternity leave within the meaning of [Directive 92/85]’.
54.      Article 2(c) of Directive 92/85 defines a worker who is breastfeeding by reference to national legislation and/or practice. The referring court states that pursuant to Article 26(1) of the LPRL: ‘the assessment of the risks … must involve a determination of the nature, degree and duration of exposure of pregnant workers or workers who have recently given birth to agents, processes or working conditions liable to adversely affect the health of the workers … in any activity likely to present a specific risk’. By virtue of Article 26(4) of the LPRL, that provision also applies to a worker ‘… during the period of breastfeeding if the working conditions are liable to affect adversely the health of the woman concerned or her child and a certificate to that effect …’ is issued by the competent authorities. The material before the Court does not provide further guidance as to how ‘the period of breastfeeding’ (as such) is defined under national law and/or practice.
55.      The Court has repeatedly held that, ‘as regards the protection of women in connection with pregnancy and maternity, … by reserving to Member States the right to retain or introduce provisions which are intended to ensure that protection, [the directive at issue] recognises the legitimacy, in terms of the principle of equal treatment of the sexes, first, of protecting a woman’s biological condition during and after pregnancy and, second, of protecting the special relationship between a woman and her child over the period which follows childbirth’. (49)
56.      It seems to me that, as a matter both of law and of nature, (50) the condition of a breastfeeding mother is ‘in connection with’ pregnancy and maternity. Article 5(3) of Directive 92/85 makes it clear that any worker covered by Article 2 shall be granted leave if it is not feasible or reasonable to move her to move her to another job. It follows that the condition of a breastfeeding mother is therefore covered by the words ‘related to pregnancy or maternity leave’ in Article 2(2)(c) of Directive 2006/54. (51)
57.      The words ‘less favourable treatment’ include a failure to apply correctly the requirements of Article 4(1) of Directive 92/85 to a woman who is breastfeeding. If that happens the person concerned is deprived of the protection she should receive under that provision and exposed to risks. That is particularly so since the employer will then not proceed to take the necessary preventive measures under Article 5 of that directive to protect her safety and health. Such adverse treatment constitutes direct discrimination on grounds of sex.
58.      I add that Article 28 (and recital 24) of Directive 2006/54 state that its provisions are ‘without prejudice’ to rules concerning the protection of women, particularly as regards pregnancy and maternity. The ordinary meaning of those words suggests that Directive 92/85 co-exists with the measures which Directive 2006/54 lays down to implement the principle of equal treatment of men and women in matters of employment and occupation. Rights relating to safety and health under Directive 92/85 are not therefore diminished, still less extinguished by Directive 2006/54.
59.      Are the conditions for triggering Article 19(1) of Directive 2006/54 met here?
60.      In my opinion the answer is ‘yes’.
61.      Ms Otero Ramos plainly considers herself to be a person wronged within the meaning of that provision. She alleges discrimination based on sex inasmuch as her employer has, she claims failed to comply with Directive 92/85. Article 19(4)(a) of Directive 2006/54 states expressly that the rules reversing the burden of proof in Article 19(1) apply to such cases.
62.      Failure to conduct an assessment in accordance with the requirements of Article 4(1), Annex I and the guidelines prescribed in Article 3(1) of Directive 92/85 constitutes less favourable treatment of a worker who is breastfeeding. (52) Such treatment is included within the definition of discrimination in Article 2(2)(c) of Directive 2006/54 it is covered by the cross-reference to Directive 92/85 in Article 19(4)(a) of Directive 2006/54 and constitutes discrimination based on sex within the meaning of that provision. It follows that Article 19(1) of Directive 2006/54 applies to such claims.
63.      Where a mother applies for a certificate and her employer conducts a risk assessment under Article 4(1) of Directive 92/85 (the first stage in the process of affording protection under that directive), the rules in Article 19(1) of Directive 2006/54 do not yet apply. That is because that process as such is within the employer’s remit. However those rules become relevant when an ensuing decision is challenged before a court or other competent authority.
64.      The onus is then upon the person concerned – here, Ms Otero Ramos – to establish a prima facie case that there has been discrimination. (53) In the main proceedings, the applicant would have to lead evidence (such as that contained in her line manager’s letter) (54) plausibly suggesting that Article 4(1) of Directive 92/85 had been misinterpreted and/or applied incorrectly. The burden of proof then shifts to the respondent in the domestic proceedings.
65.      The aim of the rules on the burden of proof is to ensure that the principle of equal treatment can be enforced effectively. (55) As the Court has already pointed out, the objective pursued by the rules of EU law governing equality between men and women is, with regard to the rights of pregnant women and women who have given birth and breastfeeding mothers, to protect those women before and after they give birth. (56) That objective, which informs both Directive 92/85 and Directive 2006/54, could not be achieved if challenges against decisions refusing the protection require the woman concerned to prove that she is at risk.
66.       In circumstances in which a woman’s employer makes an assessment under Article 4(1) of Directive 92/85 and determines that she is not at risk, it seems to me that the woman concerned cannot be required to conduct her own detailed risk assessment in order conclusively to disprove her employer’s assessment. She is unlikely to have access to the necessary occupational health specialists to assess her job, her working conditions and the risks that she and/or her child are likely to be exposed to; or the means to fund such an assessment. Such an approach would eviscerate the protection that she enjoys under Directive 92/85. In my view, Article 19 of Directive 2006/54 is intended to address precisely such a situation.
67.      That view is supported, moreover, by the principle of equality between men and women enshrined in Article 23 of the Charter, in accordance with which equality is to be ensured ‘in all areas, including employment, work and pay’. The words ‘in all areas’ indicate in favour of a reading of Article 19(1) of Directive 2006/54 that ensures that the rights of those protected by Directive 92/85 can be enforced effectively.
68.      The referring court asks whether the fact that under Spanish law the financial allowance paid in compliance with Article 11(1) of Directive 92/85 to a breastfeeding mother when she is granted leave from work is classified as a social security benefit means that such an arrangement cannot fall within the scope of the prohibition against discrimination in Article 14 of Directive 2006/54. It considers that if the period of leave were to be funded by the worker’s employer, it would be covered by that prohibition.
69.      In my view, the classification of the benefit available under national systems does not affect the applicability of the rules governing the burden of proof in Article 19 of Directive 2006/54. If a distinction were to be drawn based on whether leave is funded by the employer or a State social security scheme, the scope of Directive 2006/54 would differ according to the arrangements in the various Member States. (57) Such a result would be inconsistent with the uniform interpretation of EU law. It should for that reason be rejected. (58) It is for the referring court, in circumstances such as those at issue in the main proceedings to assess the facts and to apply the relevant provisions of Directive 2006/54. (59)
70.      I therefore conclude that the answer to Question 1 should be that where an assessment under Article 4(1) of Directive 92/85 is carried out there must be an examination of the individual situation of the worker who is breastfeeding to establish whether her safety and health or the safety and health of her child is at risk in accordance with that provision, Annex I and the guidelines laid down in Article 3(1) to that directive. A failure to carry out such an assessment correctly is less favourable treatment of the worker concerned and constitutes discrimination for the purposes of Article 2(2)(c) of Directive 2006/54. Such treatment is discrimination based on sex within the meaning of Article 19(4)(a) of Directive 2006/54 and thus falls within the scope of the rules laid down in Article 19(1) thereof that place the burden of proof upon the respondent. It is for the referring court to verify whether the facts of the case before it demonstrate discriminatory treatment. In so far as it is necessary in the context of the national proceedings for that court to determine whether further action (and if so, what action) should have been taken pursuant to Article 5 of Directive 92/85 to protect the safety and health of the worker concerned, the provisions of Article 19 of Directive 2006/54 apply to that assessment.
Questions 2, 3 and 4
Admissibility
71.      Questions 2 to 4 are based on the premiss that Question 1 is answered in the affirmative. The referring court seeks in essence to ascertain how the rules which reverse the burden of proof apply in such cases.
72.      Spain submits that Questions 2, 3 and 4 are inadmissible because the referring court in effect seeks guidance on the assessment of facts in Ms Otero Ramos’ case.
73.      I disagree.
74.      It is indeed for the national court, rather than this Court, to establish whether the circumstances in Ms Otero Ramos’ case constitute discrimination for the purposes of Directive 2006/54. However, by Questions 2 to 4 the referring court is not asking this Court to make such a finding. Rather, it seeks guidance on the interpretation of Article 19 of that directive in order to enable it to apply the relevant legal rules correctly to the evidence before it.
75.      Questions 2, 3 and 4 are therefore admissible.
Question 2
76.      By Question 2 the referring court asks whether the report from Ms Otero Ramos’ line manager (the director of the accident and emergency department of the hospital) which she submitted in support of her claim is sufficient to establish a presumption of discrimination. (60)
77.      The INSS and Spain submit that the line manager’s report is of little value. First, they consider that a line manager will automatically be biased in favour of the worker seeking access to the benefit at issue. Second, they point out that the report has not been drafted by an occupational health specialist.
78.      I find neither argument convincing.
79.      The relevance and the weight to be attached to the line manager’s report is a matter for the court dealing with the case. However, whether a line manager is biased in favour (or against) a particular worker can be determined only if relevant evidence is adduced to such effect. It cannot be assumed from the manager’s status and the existence of a hierarchical employment relationship with the person concerned that a particular bias will exist. In relation to the second point, although the line manager is not an occupational health specialist, the report was nonetheless written by a doctor who has first-hand knowledge of the individual circumstances of the applicant and her job. The line manager is able to give pertinent evidence about the applicant’s duties and the general and specific hazards to which she may be exposed.
80.      The referring court should consider that report in the light of those guidelines mentioned in Article 3(1) of Directive 92/85. The biological and physical risks outlined in the line manager’s report are echoed in the guidelines. (61) Whilst it is ultimately for that court to determine the precise value of the line manager’s report according to national procedural rules, a document of that nature is not to be dismissed out of hand on the assumption that its contents are vitiated by bias and a lack of professional expertise.
81.      Thus, in determining whether the requirements of Article 4(1) of Directive 92/85 were met in the case at issue, the referring court should examine a line manager’s report relating to the job of the worker concerned. It is for that court to establish whether such a report provides information about the individual circumstances of the worker which should be taken into account in its assessment.
Question 3
82.      Question 3 seeks to ascertain whether a declaration by an employer that a job is classified as ‘risk-free’, combined with a statement that the worker concerned is ‘fit’ for work proves without the possibility of challenge, that there has been no breach of the principle of equal treatment within the meaning of Article 19 of Directive 2006/54.
83.      In its order for reference the referring court states that certain decisions of the Spanish courts show that ‘… a strict criterion is gradually being imposed as regards the assessment of evidence relating to the existence of the relevant risk for the purposes of granting the allowance’.
84.      Whether such an approach means in effect that an irrebuttable presumption is applied in such cases so that any challenge cannot (in practice) succeed is a question of national law that must be verified by the referring court.
85.      If that were to be the case, such a result is in my view incompatible with Article 19(1) of Directive 2006/54. (62) First, it is contrary to the objective of ensuring that the principle of equal treatment can be enforced effectively. Second, it is contrary to Article 23 of the Charter as it does not protect a particularly vulnerable group of women – those who fall within the scope of Directive 92/85 – from adverse treatment based on sex. Third, it is difficult to conceive that such an approach could be a proportionate way of assessing evidence in such cases. Fourth, national rules which make it excessively difficult for a person who considers herself wronged by a failure to apply the principle of equal treatment to challenge such decisions are liable to jeopardise the aims of Directive 2006/54. (63) An irrebuttable presumption in favour of the respondent would be precisely such a rule.
86.      I therefore conclude that where rules of national law make it excessively difficult for a person who considers herself to be wronged by a breach of the principle of equal treatment to challenge that position, such rules are incompatible with Article 19 of Directive 2006/54. Whether that is the case is a matter for the national court to verify.
Question 4
87.      Question 4 is based upon the premiss that a correctly conducted assessment under Article 4(1) of Directive 92/85 might have revealed a risk to the breastfeeding mother and that it is therefore necessary to consider what action should have been taken to protect her safety and health under Article 5.
88.      That premiss is not reflected in the referring court’s description of the facts in the order for reference. However, the referring court has not indicated that such a question is outwith the scope of the main proceedings. (64) I shall therefore propose an answer to Question 4 with a view to providing the referring court with all the elements necessary in order to determine the case before it.
89.      In so far as the referring court concludes that there was a risk to Ms Otero Ramos and it becomes necessary as part of those proceedings to determine what further action should have been taken for the purposes of Article 5 of Directive 92/85, the burden of proof would lie with the respondent. Ms Otero Ramos would remain the person ‘wronged’ for the purposes of Article 19(1) of Directive 2006/54, because she was considered to be ineligible for leave and the allowance paid to breastfeeding workers during the period of absence from work.
90.      Where the results of the risk assessment carried out in accordance with Article 4 of Directive 92/85 ‘reveal a risk to the safety or health or an effect on the pregnancy or breastfeeding of a worker within the meaning, of Article 2’, Article 5(1) and (2) of that directive provide that the employer is required temporarily to adjust the working conditions and/or the working hours or, if that is not technically and/or objectively feasible or cannot reasonably be required on duly substantiated grounds, to move the worker concerned to another job, in order to avoid exposing that worker to such risks. It is only when such a move is also not feasible that Article 5(3) provides the worker is to be granted leave in accordance with national legislation and/or national practice for the whole of the period necessary to protect her safety or health’. (65)
91.      In so far as the assessment of further action pursuant to Article 5 of Directive 92/85 is part of the main proceedings, the burden of proof under Article 19(1) of Directive 2006/54 remains with the respondent.
Conclusion
92.      In the light of all the foregoing considerations I am of the opinion that the Court should answer the questions posed by the Tribunal Superior de Justicia de Galicia (Spain) as follows:
(1)      For the purposes of Article 4(1) of Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding, where an assessment is carried out there must be an examination of the individual situation of the worker who is breastfeeding to establish whether her safety and health or the safety and health of her child is at risk in accordance with that provision, Annex I and the guidelines laid down in Article 3(1) to that directive. A failure to carry out such an assessment correctly is less favourable treatment of the worker concerned and constitutes discrimination for the purposes of Article 2(2)(c) of Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation. Such treatment is also discrimination based on sex within the meaning of Article 19(4)(a) of Directive 2006/54 And thus falls within the scope of the rules laid down in Article 19(1) thereof that place the burden of proof upon the respondent.
–        It is for the referring court to verify whether the facts of the case before it demonstrate discriminatory treatment.
–        In so far as it is necessary in the context of the national proceedings for that court to determine whether further action (and, if so, what action) should have been taken pursuant to Article 5 of Directive 92/85 to protect the safety and health of the worker concerned, the provisions of Article 19 of Directive 2006/54 apply to that assessment.
(2)      In order to determine whether the requirements of Article 4(1) of Directive 92/85 were met in the case at issue, the referring court should examine a line manager’s report relating to the job of the worker concerned. It is for that court to establish whether such a report provides information about the individual circumstances of the worker which should be taken into account in its assessment.
(3)      Where rules of national law make it excessively difficult for a person who considers herself to be wronged by a breach of the principle of equal treatment to challenge that position, such rules are incompatible with Article 19 of Directive 2006/54. Whether that is the case is a matter for the national court to verify.
(4)      In so far as the assessment of further action pursuant to Article 5 of Directive 92/85 is part of the main proceedings, the burden of proof under Article 19(1) of Directive 2006/54 remains with the respondent.
1      Original language: English.
2      Directive of the European Parliament and of the Council of 5 July 2006 (OJ 2006 L 204, p. 23).
3       Council Directive (tenth individual Directive within the meaning of Article 16(1) of Directive 89/931/EEC) of 19 October 1992 (OJ 1992 L 348, p. 1).
4      OJ 2010 C 83, p. 389 (‘the Charter’).
5      Council Directive of 12 June 1989 (OJ 1989 L 183, p. 1).
6      Article 3(d).
7      Article 15.
8      Article 16(1).
9      See the first recital.
10      See the seventh and eighth recitals.
11      See the ninth recital.
12      See the tenth recital.
13      See the tenth and eleventh recitals.
14      See the twelfth recital.
15      I shall also use the expression ‘breastfeeding mother’ in this Opinion.
16      See the Communication from the Commission on the Guidelines on the assessment of chemical, physical and biological agents and industrial processes considered hazardous for the safety or health of pregnant workers and workers who have recently given birth or are breastfeeding (COM(2000) 466 final)/2 (‘the guidelines’).
17      The list includes physical, biological and chemical agents. A detailed description of those agents is set out in the table which comprises part of the guidelines referred to in Article 3(1). In certain cases, the agents listed are covered by specific EU legislation. For example, the biological agents referred to in Annex I A.(2) to Directive 92/85 are listed in Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391) (OJ 2000 L 262, p. 21). Under that directive biological agents are classified into four groups according to the level of risk of infection. Group 1 denotes the lowest risk (unlikely to cause human disease) whilst Group 4 signifies the highest risk (causes severe human disease and is a serious hazard to workers) (See Article 2 of Directive 2000/54).
18      Directive of 15 December 1997 on the burden of proof in cases of discrimination based on sex of 15 December 1997 (OJ 1998 L 14, p. 6). Directive 2006/54 repealed and replaced several directives on the implementation of the principle of equal treatment for men and women, including Directive 97/80.
19      See recital 1.
20      See recital 23.
21      See recital 24.
22      See recital 25.
23      See recital 30.
24      See points 18 to 22 above.
25      I shall refer to the declaration made by the director of human resources at the hospital together with the report of the doctor in the department of preventive medicine as ‘the hospital’s assessment’.
26      I shall refer to this two day period as ‘the material time’.
27      Whilst the body of the order for reference refers to the Juzgado No 2 of Santiago de Compostela, the introductory part of the order refers to the appeal before the referring court being made from the court in Corunna. It appears from the national case-file supplied to this Court with the order for reference that the latter is correct.
28      See the first recital and Article 1 of Directive 92/85, as well as judgment of 18 March 2014, D., C‑167/12, EU:C:2014:169, paragraphs 29 and 30 and the case-law cited.
29      See point 3above.
30      See the seventh and eighth recitals of Directive 92/85.
31      See the ninth recital of Directive 92/85.
32      See for example, judgments of 13 February 2014, TSN and YTN, C‑512/11 and C‑513/11, EU:C:2014:73, paragraph 32 and the case-law cited, and 11 of September 2014, B., C‑394/13, EU:C:2014:2199, paragraph 21 and the case-law cited.
33      See for example, judgments of 13 February 2014, TSN and YTN, C‑512/11 and C‑513/11, EU:C:2014:73, paragraph 33 and the case-law cited, and of 19 September 2013, Betriu Montull, C‑5/12, EU:C:2013:571, paragraphs 40 and 41.
34      As to the hospital’s assessment see points 25 and 26 above; as to the further evidence apparently contradicting that assessment, see point 27 above.
35      See the eleventh recital of Directive 92/85 and judgment of 1 July 2010, Parviainen, C‑471/08, EU:C:2010:391, paragraph 31 and the case-law cited.
36      Judgment of 1 July 2010, Parviainen, C‑471/08, EU:C:2010:391, paragraphs 31 and 32 and the case-law cited.
37      See the first and second indents of Article 4(1) of Directive 92/85, and see further the eleventh recital of that directive.
38      See page 6 of the guidelines.
39      See page 8 of the guidelines. The guidelines here refer back to the Commission’s document entitled ‘Guidance on risk assessment at work’ (ISBN 97-727-4278-9), which is described as constituting ‘an ideal basis for the preparation of the guidelines referred to in Article 3(1) of [Directive 92/85]’.
40      See ‘Specific points to be stressed’ at pages 8 and 9 of the guidelines.
41      See page.12 of the guidelines, which here cross-refer also to Council Directive 89/654/EEC of 30 November 1989 concerning the minimum safety and health requirements for the workplace (first individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ 1989 L 393, p.1).
42      The first entry in that table relates to ‘mental and physical fatigue and working hours’, states that ‘some pregnant and breastfeeding women may not be able to work irregular or late shifts or night work’ and identifies specific risks arising from performing such work to, inter alia, a new mother’s ability to breastfeed.
43      The first entry in that section of the table refers to ‘any biological agents in groups 2, 3 ad 4 [of the groups designated by Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work) (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ 1990 L 374, p.1) and identifies risks to a breastfeeding child from, inter alia, hepatitis and HIV.
44      The first entry in that section of the table refers to ‘manual handling of loads’ and identifies possible risks for, inter alia, those who have recently given birth or who are breastfeeding.
45      When carrying out a risk assessment employers should be aware that it is necessary to draw a distinction between the risks for pregnant women, workers who have recently given birth or are breastfeeding: see for example, the guidelines page 12.
46      See the eleventh and twelfth recitals of Directive 92/85.
47      The Hepatitis virus strains B and D (and strains yet unknown) are classified as ‘group 3 risk’ in Directive 2000/54, meaning that the agent can cause severe human disease and present a serious risk to workers.
48      Judgment of 1 July 2010, Parviainen, C‑471/08, EU:C:2010:391, paragraph 40 and the case-law cited.
49      Judgment of 30 September 2010, Roca Álvarez, C‑104/09, EU:C:2010:561, paragraph 27 and the case-law cited.
50      Only a woman who has recently given birth produces the milk required to breastfeed a child.
51      See also recital 23 of Directive 2006/54.
52      See point 57 above.
53      Judgment of 21 July 2011, Kelly, C‑104/10, EU:C:2011:506, paragraph 29.
54      See point 27 above.
55      Recital 30 of Directive 2006/54.
56      Judgment of 11 November 2010, Danosa, C‑232/09, EU:C:2010:674, paragraph 68.
57      The arrangements for implementing Article 11 of Directive 92/85 do indeed differ amongst the various Member States. See, for example, Report from the Commission on the implementation of [Directive 92/85] of 19 October 1992 on the introduction of measures to encourage improvements in the health and safety at work of pregnant workers and workers who have recently given birth or are breastfeeding, COM(1999) 100 final, pages 15 to 19.
58      See further recital 25 of Directive 2006/54.
59      See, to that effect, judgment of 11 November 2010, Danosa, C‑232/09, EU:C:2010:674, paragraph 72.
60      See point 27 above.
61      See points 43 to 47 above, and the risk assessment of generic hazards and associated situations and the risk assessment of specific hazards in the tables attached to the guidelines.
62      See further recital 30 of Directive 2006/54.
63      See for example, judgment of 21 July 2011, Kelly, C‑104/10, EU:C:2011:506, paragraphs 30 to 35.
64      See points 25 and 26 above.
65      Judgment of 1 July 2010, Gassmayr, C‑194/08, EU:C:2010:386, paragraphs 35 and 36.