Commission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations

Commission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 92/29/EEC of 31 March 1992 on the minimum safety and health requirements for improved medical treatment on board vessels OJ L 113, 30.4.1992, p. 19. , and in particular Article 8 thereof, Whereas: (1) Principle 10 of the European Pillar of Social Rights European Pillar of Social Rights, November 2017, https://ec.europa.eu/commission/priorities/deeper-and-fairer-economic-and-monetary-union/european-pillar-social-rights_en , proclaimed at Gothenburg on 17 November 2017, states that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes improved medical treatment on board vessels. (2) The implementation of the directives related to the health and safety of workers at work, including Directive 92/29/EEC, was the subject of an ex post evaluation, referred to as REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document SWD(2017) 10 final , concludes, among other things, that the list of mandatory medical supplies in Annex II of Directive 92/29/EEC needs to be updated and that coherence with international instruments should be enhanced. (3) In its Communication Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy COM(2017) 12 final , the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational safety and health confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to update the list of mandatory medical supplies in Annex II to Directive 92/29/EEC. (4) Directive 92/29/EEC lays down minimum safety and health requirements for improved medical treatment for persons carrying out an occupation on board a vessel. It lists the medical supplies required on board and addresses how responsibilities are assigned, information and training, and inspection. (5) Annex II to Directive 92/29/EEC contains a non-exhaustive list of medical supplies required on board, including medicines, medical equipment and antidotes. The requirements as regards the medical supplies vary according to the category of vessel as defined in Annex I of that Directive. (6) It is appropriate to amend Annex II to Directive 92/29/EEC in the light of the scientific and medical developments that have taken place since its adoption, particularly as regards the new medicines and medical equipment that have become available, and medicines or medical equipment which are not required to be carried on board any more. Moreover, in several instances, medical practice has shown that the wording of existing entries in Annex II to Directive 92/29/EEC needs to be updated or adapted to reflect current practices more closely.

(7) Vessels staying very close to shore or with no cabin accommodation belonging to category C should be given particular consideration as these vessels tend to be smaller and may lack the space for full medical supplies. Annex II to Directive 92/29/EEC should therefore allow Member States to consider, under exceptional circumstances, the use of alternatives (medicines or medical equipment) for objectively justified reasons. Given the specificities of category C vessels, there is no need to carry certain items on board and therefore the list of medicines and medical equipment of that category should be slightly shortened. (8) Annex IV to Directive 92/29/EEC should be amended to take into account the amendment of Annex II, because Annex IV lays down a general framework for the inspection of the vessels’ medical supplies and as such is closely related to Annex II and reproduces its contents for inspection purposes. (9) Annexes II and IV to Directive 92/29/EEC should be amended to take into account international instruments, such as the International Medical Guide for Ships International medical guide for ships: including the ship’s medicine chest. 3rd ed., World Health Organization, 2007 (ISBN 978 92 4 154720 8) , as well as to maintain the existing levels of protection for persons carrying out an occupation on board a vessel, and to reflect scientific and medical developments in the area, requiring merely technical adjustments at the workplace. (10) The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy that are required to keep the Union’s occupational safety and health legislation effective and fit-for-purpose. (11) In its Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All Advisory Committee for Safety and Health at Work Doc. 1718/2017 , adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Annexes II and IV to Directive 92/29/EEC should be updated. (12) In a subsequent Opinion on the Technical updates of annexes of the Directive Medical Treatment on board (92/29) Advisory Committee for Safety and Health at Work Doc. 444/18 , adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that Annexes II and IV to Directive 92/29/EEC should be updated to take into account the latest technological and medical developments in the field. (13) The Commission was assisted by experts representing the Member States, who provided technical and scientific support. (14) In accordance with the Joint Political Declaration on explanatory documents OJ C 369, 17.12.2011, p. 14. , adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(15) The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 8 of Directive 92/29/EEC, HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II and IV to Directive 92/29/EEC are replaced by the text in the Annex to this Directive.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 at the latest. They shall forthwith communicate to the Commission the text of those provisions. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States. Done at Brussels, 24 October 2019. For the Commission The President Jean-Claude Juncker

Annex

ANNEX (1) Annex II to Directive 92/29/EEC is replaced by the following: (2) Annex IV to Directive 92/29/EEC is replaced by the following:

Annex

ANNEX II MEDICAL SUPPLIES (NON-EXHAUSTIVE LIST) () (Article 1(d)) () In light of Article 2(1)(a) Member States may, under exceptional circumstances, consider the use of alternative medicines or medical equipment for objectively justified reasons. I. MEDICINES Categories of vesselsABC1. Cardiovascular(a) Cardio-circulatory sympathomimeticsxx(b) Anti-angina preparationsxxx(c) Diureticsxx(d) Anti-haemorrhagics including uterotonics if there are women on boardxx(e) Anti-hypertensivexx2. Gastro-intestinal system(a) Medicines for gastric and duodenal disorders— Medicine for treatment of stomach ulcer and gastritisxx— Anti-acid mucous dressingsxx(b) Anti-emeticsxx(c) Laxativesx(d) Anti-diarrhoealsxxx(e) Haemorrhoid preparationsxx3. Analgesics and anti-spasmodics(a) Analgesics, anti-pyretics and anti-inflammatory preparationsxxx(b) Powerful analgesicsxx(c) Spasmolyticsxx4. Nervous system(a) Anxiolyticsxx(b) Neurolepticsxx(c) Seasickness remediesxxx(d) Anti-epilepticsxx5. Anti-allergics and anti-anaphylactics(a) Anti-histaminicsxx(b) Glucocorticoidsxx 6. Respiratory system(a) Bronchiospasm preparationsxx(b) Anti-tussivesxx(c) Medicines used for colds and sinusitisxx7. Anti-infection(a) Antibiotics (at least two classes)xx(b) Anti-parasiticsxx(c) Anti-tetanus vaccines and immunoglobulinsxx(d) Anti-malaria medicines, carriage shall be dependent upon operational areaxx8. Compounds promoting rehydration, caloric intake and plasma expansionxx9. Medicines for external use(a) Skin medicines— Antiseptic solutionsxxx— Antibiotic ointmentsxx— Anti-inflammatory and analgesic ointmentsxx— Anti-mycotic skin creamsx— Burn preparationsxxx(b) Eye medicines— Antibiotic and anti-inflammatoryxx— Anaesthetic dropsxx— Saline solution for eyewashxxx— Hypotonic myotic dropsxx(c) Ear medicines— Anaesthetic and anti-inflammatory solutionsxx(d) Medicines for oral and throat infections— Antiseptic mouthwashesxx(e) Local anaesthetics— Local anaesthetics using freezingx— Local anaesthetics given by subcutaneous injectionxx

II. MEDICAL EQUIPMENT Under the conditions of use prescribed by national laws and/or practices Categories of vesselsABC1. Resuscitation equipment— Ambu bag (or equivalent); supplied with large, medium and small masksxx— Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen containerxx— Mechanical aspirator to clear upper respiratory passagesxx2. Dressing and suturing equipment— Tourniquetsxxx— Disposable suture stapler or suture kit with needlesxx— Adhesive elastic bandagexxx— Gauze stripsxx— Tubular gauze for finger bandagesx— Sterile gauze compressesxxx— Sterile sheet for burns victimsxx— Triangular slingxx— Disposable glovesxxx— Adhesive dressingsxxx— Sterile compression bandagesxxx— Adhesive sutures or zinc oxide bandagesxxx— Non-absorbable sutures with needlesx— Vaseline gauzexx3. Instruments— Disposable scalpelsx— Instrument box made of suitable materialxx— Scissorsxx— Dissecting forcepsxx— Haemostatic clampsxx— Needle forcepsx— Disposable razorsx4. Examination and monitoring equipment— Disposable tongue depressorsxx— Reactive strips for urine analysisx— Temperature chartsx— Medical evacuation sheetsxx— Stethoscopexx— Sphygmomanometerxx — Medical thermometerxx— Hypothermic thermometerxx— Quick malaria test, carriage shall be dependent upon operational areaxx5. Equipment for injection, perfusion, puncture and catheterisation— Bladder drainage equipment (suitable for men and women)x— Intravenous infusion setxx— Disposable syringes and needlesxx6. General medical equipment— Personal protective medical and nursing equipmentxx— Bedpanx— Hot-water bottlex— Urine bottlex— Ice bagx7. Immobilisation and setting equipment— Set of splints of different sizes for the extremitiesxx— Collar for neck immobilisationxx8. Disinfection, disinsectisation and prophylaxis— Water-disinfection compoundx— Liquid insecticidex— Powder insecticidex III. ANTIDOTES

1. Medicines— General— Cardio-vascular— Gastro-intestinal system— Nervous system— Respiratory system— Anti-infective— For external use2. Medical equipment— Necessary for the administration of oxygen (including maintenance requisites) Note: For the detailed implementation of Section III, Member States may refer to the IMO Medical First Aid Guide for use in accidents involving dangerous goods (MFAG) contained in the 1990 consolidated edition of the IMO International Maritime Dangerous Goods Code, as amended. Any adaptation of Section III in implementation of Article 8 may take account, inter alia, of any updating of the MFAG.

Annex

ANNEX IV General Framework for the Inspection of Vessels’ Medical Supplies (Article 2(1)(c), Article 3(3)) SECTION A CATEGORY A VESSELS I. Details of the vessel Name: … Flag: … Home port: … II. Medical supplies Under the conditions of use prescribed by national laws and/or practices. Quantities requiredQuantities actually carried on boardRemarks (in particular, any expiry date)1. MEDICINE1.1. Cardiovascular(a) Cardio-circulatory sympathomimetics000(b) Anti-angina preparations000(c) Diuretics000(d) Anti-haemorrhagics including uterotonics if there are women on board000(e) Anti-hypertensive0001.2. Gastro-intestinal system(a) Medicines for gastric and duodenal disorders000— Medicine for treatment of stomach ulcer and gastritis000— Anti-acid mucous dressings000(b) Anti-emetics000(c) Laxatives000(d) Anti-diarrhoeals000(e) Haemorrhoid preparations000

1.3. Analgesics and anti-spasmodics(a) Analgesics, anti-pyretics and anti-inflammatory preparations000(b) Powerful analgesics000(c) Spasmolytics0001.4. Nervous system(a) Anxiolytics000(b) Neuroleptics000(c) Seasickness remedies000(d) Anti-epileptics0001.5. Anti-allergics and anti-anaphylactics(a) Anti-histaminics000(b) Glucocorticoids0001.6. Respiratory system(a) Bronchiospasm preparations000(b) Anti-tussives000(c) Medicines used for colds and sinusitis0001.7. Anti-infection(a) Antibiotics (at least two classes)000(b) Anti-parasitics000(c) Anti-tetanus vaccines and immunoglobulins000(d) Anti-malaria medicines, carriage shall be dependent upon operational area0001.8. Compounds promoting rehydration, caloric intake and plasma expansion0001.9. Medicines for external use(a) Skin medicines000— Antiseptic solutions000— Antibiotic ointments000— Anti-inflammatory and analgesic ointments000— Anti-mycotic skin creams000— Burn preparations000(b) Eye medicines000— Antibiotic and anti-inflammatory000— Anaesthetic drops000— Saline solution for eyewash000— Hypotonic myotic drops000 (c) Ear medicines000— Anaesthetic and anti-inflammatory solutions000(d) Medicines for oral and throat infections000— Antiseptic mouthwashes000(e) Local anaesthetics000— Local anaesthetics using freezing000— Local anaesthetics given by subcutaneous injection0002. MEDICAL EQUIPMENT2.1. Resuscitation equipment— Ambu bag (or equivalent); supplied with large, medium and small masks000— Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container000— Mechanical aspirator to clear upper respiratory passages0002.2. Dressing and suturing equipment— Tourniquets000— Disposable suture stapler or suture kit with needles000— Adhesive elastic bandage000— Gauze strips000— Tubular gauze for finger bandages000— Sterile gauze compresses000— Sterile sheet for burns victims000— Triangular sling000— Disposable gloves000— Adhesive dressings000— Sterile compression bandages000— Adhesive sutures or zinc oxide bandages000— Non-absorbable sutures with needles000— Vaseline gauze0002.3. Instruments— Disposable scalpels000— Instrument box made of suitable material000— Scissors000— Dissecting forceps000 — Haemostatic clamps000— Needle forceps000— Disposable razors0002.4. Examination and monitoring equipment000— Disposable tongue depressors000— Reactive strips for urine analysis000— Temperature charts000— Medical evacuation sheets000— Stethoscope000— Sphygmomanometer000— Medical thermometer000— Hypothermic thermometer000—Quick malaria test, carriage shall be dependent upon operational area0002.5. Equipment for injection, perfusion, puncture and catheterisation000— Bladder drainage equipment (suitable for men and women)000— Intravenous infusion set000— Disposable syringes and needles0002.6. General medical equipment000— Personal protective medical and nursing equipment000— Bedpan000— Hot-water bottle000— Urine bottle000— Ice bag0002.7. Immobilisation and setting equipment000— Set of splints of different sizes for the extremities000— Collar for neck immobilisation0002.8. Disinfection, disinsectisation and prophylaxis000— Water-disinfection compound000— Liquid insecticide000— Powder insecticide0003. ANTIDOTES3.1. General0003.2. Cardio-vascular0003.3. Gastro-intestinal system0003.4. Nervous system000

3.5. Respiratory system0003.6. Anti-infective0003.7. For external use0003.8. Other0003.9. Necessary for the administration of oxygen (including maintenance requisites)000 Venue and date: … Captain’s signature: … Authorisation by competent person or authority: … SECTION B CATEGORY B VESSELS I. Details of the vessel Name: … Flag: … Home port: … II. Medical supplies Under the conditions of use prescribed by national laws and/or practices. Quantities requiredQuantities actually carried on boardRemarks (in particular, any expiry date)1. MEDICINE1.1. Cardiovascular(a) Cardio-circulatory sympathomimetics000(b) Anti-angina preparations000(c) Diuretics000(d) Anti-haemorrhagics including uterotonics if there are women on board000(e) Anti-hypertensive0001.2. Gastro-intestinal system(a) Medicines for gastric and duodenal disorders000— Medicine for treatment of stomach ulcer and gastritis000— Anti-acid mucous dressings000(b) Anti-emetics000(c) Anti-diarrhoeals000(d) Haemorrhoid preparations0001.3. Analgesics and anti-spasmodics(a) Analgesics, anti-pyretics and anti-inflammatory preparations000(b) Powerful analgesics000(c) Spasmolytics0001.4. Nervous system(a) Anxiolytics000(b) Neuroleptics000(c) Seasickness remedies000(d) Anti-epileptics0001.5. Anti-allergics and anti-anaphylactics(a) Anti-histaminics000(b) Glucocorticoids000 1.6. Respiratory system(a) Bronchiospasm preparations000(b) Anti-tussives000(c) Medicines used for colds and sinusitis0001.7. Anti-infection(a) Antibiotics (at least two classes)000(b) Anti-parasitics000(c) Anti-tetanus vaccines and immunoglobulins000(d) Anti-malaria medicines, carriage shall be dependent upon operational area0001.8. Compounds promoting rehydration, caloric intake and plasma expansion0001.9. Medicines for external use(a) Skin medicines000— Antiseptic solutions000— Antibiotic ointments000— Anti-inflammatory and analgesic ointments000— Burn preparations000(b) Eye medicines000— Antibiotic and anti-inflammatory000— Anaesthetic drops000— Saline solution for eyewash000— Hypotonic myotic drops000(c) Ear medicines000— Anaesthetic and anti-inflammatory solutions000(d) Medicines for oral and throat infections000— Antiseptic mouthwashes000(e) Local anaesthetics000— Local anaesthetics given by subcutaneous injection0002. MEDICAL EQUIPMENT2.1 Resuscitation equipment— Ambu bag (or equivalent); supplied with large, medium and small masks000— Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container000— Mechanical aspirator to clear upper respiratory passages000 2.2. Dressing and suturing equipment— Tourniquets000— Disposable suture stapler or suture kit with needles000— Adhesive elastic bandage000— Gauze strips000— Sterile gauze compresses000— Sterile sheet for burns victims000— Triangular sling000— Disposable gloves000— Adhesive dressings000— Sterile compression bandages000— Adhesive sutures or zinc oxide bandages000— Vaseline gauze0002.3. Instruments— Instrument box made of suitable material000— Scissors000— Dissecting forceps000— Haemostatic clamps0002.4. Examination and monitoring equipment000— Disposable tongue depressors000— Medical evacuation sheets000— Stethoscope000— Sphygmomanometer000— Medical thermometer000— Hypothermic thermometer000—Quick malaria test, carriage shall be dependent upon operational area0002.5.Equipment for injection, perfusion, puncture and catheterisation000— Intravenous infusion set000— Disposable syringes and needles0002.6.General medical equipment000— Personal protective medical and nursing equipment0002.7.Immobilisation and setting equipment000— Set of splints of different sizes for the extremities000— Collar for neck immobilisation000

1. ANTIDOTES3.1. General0003.2. Cardio-vascular0003.3. Gastro-intestinal system0003.4. Nervous system0003.5. Respiratory system0003.6. Anti-infective0003.7. For external use0003.8. Other0003.9. Necessary for the administration of oxygen (including maintenance requisites)000 Venue and date: … Captain’s signature: … Authorisation by competent person or authority: … SECTION C CATEGORY C VESSELS I. Details of the vessel Name: … Flag: … Home port: … II. Medical supplies Quantities requiredQuantities actually carried on boardRemarks (in particular, any expiry date)1. MEDICINE1.1. Cardiovascular(a) Anti-angina preparations0001.2. Gastro-intestinal system(a) Anti-diarrhoeals0001.3. Analgesics and anti-spasmodics(a) Analgesics, anti-pyretics and anti-inflammatory preparations0001.4. Nervous system(c) Seasickness remedies0001.5. Medicines for external use(a) Skin medicines000— Antiseptic solutions000— Burn preparations000(b) Eye medicines000— Saline solution for eyewash0002. MEDICAL EQUIPMENT2.1. Dressing and suturing equipment— Tourniquets000— Adhesive elastic bandage000— Sterile gauze compresses000— Disposable gloves000— Adhesive dressings000— Sterile compression bandages000— Adhesive sutures or zinc oxide bandages0003. ANTIDOTES3.1. General0003.2. Cardio-vascular0003.3. Gastro-intestinal system0003.4. Nervous system000 3.5. Respiratory system0003.6. Anti-infective0003.7. For external use0003.8. Other0003.9. Necessary for the administration of oxygen (including maintenance requisites)000 Venue and date: … Captain’s signature: … Authorisation by competent person or authority: …