title: 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

text:
                  31.10.2019

                  EN

                  Official Journal of the European Union

                  L 279/80

         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 (1), and in particular Article 8 thereof,
         Whereas:

                     (1)

                     Principle 10 of the European Pillar of Social Rights (2), 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 (3), 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’ (4), 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confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground.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 (5), 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’ (6), 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)’ (7), 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 (8), 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

            (1)  OJ L 113, 30.4.1992, p. 19.

            (2)  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

            (3)  SWD(2017) 10 final

            (4)  COM(2017) 12 final

            (5)  International medical guide for ships: including the ship’s medicine chest. 3rd ed., World Health Organization, 2007 (ISBN 978 92 4 154720 8)

            (6)  Advisory Committee for Safety and Health at Work Doc. 1718/2017

            (7)  Advisory Committee for Safety and Health at Work Doc. 444/18

            (8)  OJ C 369, 17.12.2011, p. 14.

            ANNEX

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

                     ‘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 vessels

                                 A

                                 B

                                 C

                                 1. Cardiovascular

                                 (a) Cardio-circulatory sympathomimetics

                                 x

                                 x

                                 (b) Anti-angina preparations

                                 x

                                 x

                                 x

                                 (c) Diuretics

                                 x

                                 x

                                 (d) Anti-haemorrhagics including uterotonics if there are women on board

                                 x

                                 x

                                 (e) Anti-hypertensive

                                 x

                                 x

                                 2. Gastro-intestinal system

                                 (a) Medicines for gastric and duodenal disorders

                                 — Medicine for treatment of stomach ulcer and gastritis

                                 x

                                 x

                                 — Anti-acid mucous dressings

                                 x

                                 x

                                 (b) Anti-emetics

                                 x

                                 x

                                 (c) Laxatives

                                 x

                                 (d) Anti-diarrhoeals

                                 x

                                 x

                                 x

                                 (e) Haemorrhoid preparations

                                 x

                                 x

                                 3. Analgesics and anti-spasmodics

                                 (a) Analgesics, anti-pyretics and anti-inflammatory preparations

                                 x

                                 x

                                 x

                                 (b) Powerful analgesics

                                 x

                                 x

                                 (c) Spasmolytics

                                 x

                                 x

                                 4. Nervous system

                                 (a) Anxiolytics

                                 x

                                 x

                                 (b) Neuroleptics

                                 x

                                 x

                                 (c) Seasickness remedies

                                 x

                                 x

                                 x

                                 (d) Anti-epileptics

                                 x

                                 x

                                 5. Anti-allergics and anti-anaphylactics

                                 (a) Anti-histaminics

                                 x

                                 x

                                 (b) Glucocorticoids

                                 x

                                 x

                                 6. Respiratory system

                                 (a) Bronchiospasm preparations

                                 x

                                 x

                                 (b) Anti-tussives

                                 x

                                 x

                                 (c) Medicines used for colds and sinusitis

                                 x

                                 x

                                 7. Anti-infection

                                 (a) Antibiotics (at least two classes)

                                 x

                                 x

                                 (b) Anti-parasitics

                                 x

                                 x

                                 (c) Anti-tetanus vaccines and immunoglobulins

                                 x

                                 x

                                 (d) Anti-malaria medicines, carriage shall be dependent upon operational area

                                 x

                                 x

                                 8. Compounds promoting rehydration, caloric intake and plasma expansion

                                 x

                                 x

                                 9. Medicines for external use

                                 (a) Skin medicines

                                 — Antiseptic solutions

                                 x

                                 x

                                 x

                                 — Antibiotic ointments

                                 x

                                 x

                                 — Anti-inflammatory and analgesic ointments

                                 x

                                 x

                                 — Anti-mycotic skin creams

                                 x

                                 — Burn preparations

                                 x

                                 x

                                 x

                                 (b) Eye medicines

                                 — Antibiotic and anti-inflammatory

                                 x

                                 x

                                 — Anaesthetic drops

                                 x

                                 x

                                 — Saline solution for eyewash

                                 x

                                 x

                                 x

                                 — Hypotonic myotic drops

                                 x

                                 x

                                 (c) Ear medicines

                                 — Anaesthetic and anti-inflammatory solutions

                                 x

                                 x

                                 (d) Medicines for oral and throat infections

                                 — Antiseptic mouthwashes

                                 x

                                 x

                                 (e) Local anaesthetics

                                 — Local anaesthetics using freezing

                                 x

                                 — Local anaesthetics given by subcutaneous injection

                                 x

                                 x

                           II.
                           MEDICAL EQUIPMENT

                                    Categories of vessels

                                 A

                                 B

                                 C

                                 1. Resuscitation equipment

                                 — Ambu bag (or equivalent); supplied with large, medium and small masks

                                 x

                                 x

                                 — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (1)

                                 x

                                 x

                                 — Mechanical aspirator to clear upper respiratory passages

                                 x

                                 x

                                 2. Dressing and suturing equipment

                                 — Tourniquets

                                 x

                                 x

                                 x

                                 — Disposable suture stapler or suture kit with needles

                                 x

                                 x

                                 — Adhesive elastic bandage

                                 x

                                 x

                                 x

                                 — Gauze strips

                                 x

                                 x

                                 — Tubular gauze for finger bandages

                                 x

                                 — Sterile gauze compresses

                                 x

                                 x

                                 x

                                 — Sterile sheet for burns victims

                                 x

                                 x

                                 — Triangular sling

                                 x

                                 x

                                 — Disposable gloves

                                 x

                                 x

                                 x

                                 — Adhesive dressings

                                 x

                                 x

                                 x

                                 — Sterile compression bandages

                                 x

                                 x

                                 x

                                 — Adhesive sutures or zinc oxide bandages

                                 x

                                 x

                                 x

                                 — Non-absorbable sutures with needles

                                 x

                                 — Vaseline gauze

                                 x

                                 x

                                 3. Instruments

                                 — Disposable scalpels

                                 x

                                 — Instrument box made of suitable material

                                 x

                                 x

                                 — Scissors

                                 x

                                 x

                                 — Dissecting forceps

                                 x

                                 x

                                 — Haemostatic clamps

                                 x

                                 x

                                 — Needle forceps

                                 x

                                 — Disposable razors

                                 x

                                 4. Examination and monitoring equipment

                                 — Disposable tongue depressors

                                 x

                                 x

                                 — Reactive strips for urine analysis

                                 x

                                 — Temperature charts

                                 x

                                 — Medical evacuation sheets

                                 x

                                 x

                                 — Stethoscope

                                 x

                                 x

                                 — Sphygmomanometer

                                 x

                                 x

                                 — Medical thermometer

                                 x

                                 x

                                 — Hypothermic thermometer

                                 x

                                 x

                                 — Quick malaria test, carriage shall be dependent upon operational area

                                 x

                                 x

                                 5. Equipment for injection, perfusion, puncture and catheterisation

                                 — Bladder drainage equipment (suitable for men and women)

                                 x

                                 — Intravenous infusion set

                                 x

                                 x

                                 — Disposable syringes and needles

                                 x

                                 x

                                 6. General medical equipment

                                 — Personal protective medical and nursing equipment

                                 x

                                 x

                                 — Bedpan

                                 x

                                 — Hot-water bottle

                                 x

                                 — Urine bottle

                                 x

                                 — Ice bag

                                 x

                                 7. Immobilisation and setting equipment

                                 — Set of splints of different sizes for the extremities

                                 x

                                 x

                                 — Collar for neck immobilisation

                                 x

                                 x

                                 8. Disinfection, disinsectisation and prophylaxis

                                 — Water-disinfection compound

                                 x

                                 — Liquid insecticide

                                 x

                                 — Powder insecticide

                                 x

                           III.
                           ANTIDOTES

                                 1. Medicines

                                 — General

                                 — Cardio-vascular

                                 — Gastro-intestinal system

                                 — Nervous system

                                 — Respiratory system

                                 — Anti-infective

                                 — For external use

                                 2. 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.

               ’

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

                     ‘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

                                 Quantities required

                                 Quantities actually carried on board

                                 Remarks (in particular, any expiry date)

                                 1. MEDICINE

                                 1.1. Cardiovascular

                                 (a) Cardio-circulatory sympathomimetics

                                 0

                                 0

                                 0

                                 (b) Anti-angina preparations

                                 0

                                 0

                                 0

                                 (c) Diuretics

                                 0

                                 0

                                 0

                                 (d) Anti-haemorrhagics including uterotonics if there are women on board

                                 0

                                 0

                                 0

                                 (e) Anti-hypertensive

                                 0

                                 0

                                 0

                                 1.2. Gastro-intestinal system

                                 (a) Medicines for gastric and duodenal disorders

                                 0

                                 0

                                 0

                                 — Medicine for treatment of stomach ulcer and gastritis

                                 0

                                 0

                                 0

                                 — Anti-acid mucous dressings

                                 0

                                 0

                                 0

                                 (b) Anti-emetics

                                 0

                                 0

                                 0

                                 (c) Laxatives

                                 0

                                 0

                                 0

                                 (d) Anti-diarrhoeals

                                 0

                                 0

                                 0

                                 (e) Haemorrhoid preparations

                                 0

                                 0

                                 0

                                 1.3. Analgesics and anti-spasmodics

                                 (a) Analgesics, anti-pyretics and anti-inflammatory preparations

                                 0

                                 0

                                 0

                                 (b) Powerful analgesics

                                 0

                                 0

                                 0

                                 (c) Spasmolytics

                                 0

                                 0

                                 0

                                 1.4. Nervous system

                                 (a) Anxiolytics

                                 0

                                 0

                                 0

                                 (b) Neuroleptics

                                 0

                                 0

                                 0

                                 (c) Seasickness remedies

                                 0

                                 0

                                 0

                                 (d) Anti-epileptics

                                 0

                                 0

                                 0

                                 1.5. Anti-allergics and anti-anaphylactics

                                 (a) Anti-histaminics

                                 0

                                 0

                                 0

                                 (b) Glucocorticoids

                                 0

                                 0

                                 0

                                 1.6. Respiratory system

                                 (a) Bronchiospasm preparations

                                 0

                                 0

                                 0

                                 (b) Anti-tussives

                                 0

                                 0

                                 0

                                 (c) Medicines used for colds and sinusitis

                                 0

                                 0

                                 0

                                 1.7. Anti-infection

                                 (a) Antibiotics (at least two classes)

                                 0

                                 0

                                 0

                                 (b) Anti-parasitics

                                 0

                                 0

                                 0

                                 (c) Anti-tetanus vaccines and immunoglobulins

                                 0

                                 0

                                 0

                                 (d) Anti-malaria medicines, carriage shall be dependent upon operational area

                                 0

                                 0

                                 0

                                 1.8. Compounds promoting rehydration, caloric intake and plasma expansion

                                 0

                                 0

                                 0

                                 1.9. Medicines for external use

                                 (a) Skin medicines

                                 0

                                 0

                                 0

                                 — Antiseptic solutions

                                 0

                                 0

                                 0

                                 — Antibiotic ointments

                                 0

                                 0

                                 0

                                 — Anti-inflammatory and analgesic ointments

                                 0

                                 0

                                 0

                                 — Anti-mycotic skin creams

                                 0

                                 0

                                 0

                                 — Burn preparations

                                 0

                                 0

                                 0

                                 (b) Eye medicines

                                 0

                                 0

                                 0

                                 — Antibiotic and anti-inflammatory

                                 0

                                 0

                                 0

                                 — Anaesthetic drops

                                 0

                                 0

                                 0

                                 — Saline solution for eyewash

                                 0

                                 0

                                 0

                                 — Hypotonic myotic drops

                                 0

                                 0

                                 0

                                 (c) Ear medicines

                                 0

                                 0

                                 0

                                 — Anaesthetic and anti-inflammatory solutions

                                 0

                                 0

                                 0

                                 (d) Medicines for oral and throat infections

                                 0

                                 0

                                 0

                                 — Antiseptic mouthwashes

                                 0

                                 0

                                 0

                                 (e) Local anaesthetics

                                 0

                                 0

                                 0

                                 — Local anaesthetics using freezing

                                 0

                                 0

                                 0

                                 — Local anaesthetics given by subcutaneous injection

                                 0

                                 0

                                 0

                                 2. MEDICAL EQUIPMENT

                                 2.1. Resuscitation equipment

                                 — Ambu bag (or equivalent); supplied with large, medium and small masks

                                 0

                                 0

                                 0

                                 — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (2)

                                 0

                                 0

                                 0

                                 — Mechanical aspirator to clear upper respiratory passages

                                 0

                                 0

                                 0

                                 2.2. Dressing and suturing equipment

                                 — Tourniquets

                                 0

                                 0

                                 0

                                 — Disposable suture stapler or suture kit with needles

                                 0

                                 0

                                 0

                                 — Adhesive elastic bandage

                                 0

                                 0

                                 0

                                 — Gauze strips

                                 0

                                 0

                                 0

                                 — Tubular gauze for finger bandages

                                 0

                                 0

                                 0

                                 — Sterile gauze compresses

                                 0

                                 0

                                 0

                                 — Sterile sheet for burns victims

                                 0

                                 0

                                 0

                                 — Triangular sling

                                 0

                                 0

                                 0

                                 — Disposable gloves

                                 0

                                 0

                                 0

                                 — Adhesive dressings

                                 0

                                 0

                                 0

                                 — Sterile compression bandages

                                 0

                                 0

                                 0

                                 — Adhesive sutures or zinc oxide bandages

                                 0

                                 0

                                 0

                                 — Non-absorbable sutures with needles

                                 0

                                 0

                                 0

                                 — Vaseline gauze

                                 0

                                 0

                                 0

                                 2.3. Instruments

                                 — Disposable scalpels

                                 0

                                 0

                                 0

                                 — Instrument box made of suitable material

                                 0

                                 0

                                 0

                                 — Scissors

                                 0

                                 0

                                 0

                                 — Dissecting forceps

                                 0

                                 0

                                 0

                                 — Haemostatic clamps

                                 0

                                 0

                                 0

                                 — Needle forceps

                                 0

                                 0

                                 0

                                 — Disposable razors

                                 0

                                 0

                                 0

                                 2.4. Examination and monitoring equipment

                                 0

                                 0

                                 0

                                 — Disposable tongue depressors

                                 0

                                 0

                                 0

                                 — Reactive strips for urine analysis

                                 0

                                 0

                                 0

                                 — Temperature charts

                                 0

                                 0

                                 0

                                 — Medical evacuation sheets

                                 0

                                 0

                                 0

                                 — Stethoscope

                                 0

                                 0

                                 0

                                 — Sphygmomanometer

                                 0

                                 0

                                 0

                                 — Medical thermometer

                                 0

                                 0

                                 0

                                 — Hypothermic thermometer

                                 0

                                 0

                                 0

                                 —Quick malaria test, carriage shall be dependent upon operational area

                                 0

                                 0

                                 0

                                 2.5. Equipment for injection, perfusion, puncture and catheterisation

                                 0

                                 0

                                 0

                                 — Bladder drainage equipment (suitable for men and women)

                                 0

                                 0

                                 0

                                 — Intravenous infusion set

                                 0

                                 0

                                 0

                                 — Disposable syringes and needles

                                 0

                                 0

                                 0

                                 2.6. General medical equipment

                                 0

                                 0

                                 0

                                 — Personal protective medical and nursing equipment

                                 0

                                 0

                                 0

                                 — Bedpan

                                 0

                                 0

                                 0

                                 — Hot-water bottle

                                 0

                                 0

                                 0

                                 — Urine bottle

                                 0

                                 0

                                 0

                                 — Ice bag

                                 0

                                 0

                                 0

                                 2.7. Immobilisation and setting equipment

                                 0

                                 0

                                 0

                                 — Set of splints of different sizes for the extremities

                                 0

                                 0

                                 0

                                 — Collar for neck immobilisation

                                 0

                                 0

                                 0

                                 2.8. Disinfection, disinsectisation and prophylaxis

                                 0

                                 0

                                 0

                                 — Water-disinfection compound

                                 0

                                 0

                                 0

                                 — Liquid insecticide

                                 0

                                 0

                                 0

                                 — Powder insecticide

                                 0

                                 0

                                 0

                                 3. ANTIDOTES

                                 3.1. General

                                 0

                                 0

                                 0

                                 3.2. Cardio-vascular

                                 0

                                 0

                                 0

                                 3.3. Gastro-intestinal system

                                 0

                                 0

                                 0

                                 3.4. Nervous system

                                 0

                                 0

                                 0

                                 3.5. Respiratory system

                                 0

                                 0

                                 0

                                 3.6. Anti-infective

                                 0

                                 0

                                 0

                                 3.7. For external use

                                 0

                                 0

                                 0

                                 3.8. Other

                                 0

                                 0

                                 0

                                 3.9. Necessary for the administration of oxygen (including maintenance requisites)

                                 0

                                 0

                                 0

                           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

                                 Quantities required

                                 Quantities actually carried on board

                                 Remarks (in particular, any expiry date)

                                 1. MEDICINE

                                 1.1. Cardiovascular

                                 (a) Cardio-circulatory sympathomimetics

                                 0

                                 0

                                 0

                                 (b) Anti-angina preparations

                                 0

                                 0

                                 0

                                 (c) Diuretics

                                 0

                                 0

                                 0

                                 (d) Anti-haemorrhagics including uterotonics if there are women on board

                                 0

                                 0

                                 0

                                 (e) Anti-hypertensive

                                 0

                                 0

                                 0

                                 1.2. Gastro-intestinal system

                                 (a) Medicines for gastric and duodenal disorders

                                 0

                                 0

                                 0

                                 — Medicine for treatment of stomach ulcer and gastritis

                                 0

                                 0

                                 0

                                 — Anti-acid mucous dressings

                                 0

                                 0

                                 0

                                 (b) Anti-emetics

                                 0

                                 0

                                 0

                                 (c) Anti-diarrhoeals

                                 0

                                 0

                                 0

                                 (d) Haemorrhoid preparations

                                 0

                                 0

                                 0

                                 1.3. Analgesics and anti-spasmodics

                                 (a) Analgesics, anti-pyretics and anti-inflammatory preparations

                                 0

                                 0

                                 0

                                 (b) Powerful analgesics

                                 0

                                 0

                                 0

                                 (c) Spasmolytics

                                 0

                                 0

                                 0

                                 1.4. Nervous system

                                 (a) Anxiolytics

                                 0

                                 0

                                 0

                                 (b) Neuroleptics

                                 0

                                 0

                                 0

                                 (c) Seasickness remedies

                                 0

                                 0

                                 0

                                 (d) Anti-epileptics

                                 0

                                 0

                                 0

                                 1.5. Anti-allergics and anti-anaphylactics

                                 (a) Anti-histaminics

                                 0

                                 0

                                 0

                                 (b) Glucocorticoids

                                 0

                                 0

                                 0

                                 1.6. Respiratory system

                                 (a) Bronchiospasm preparations

                                 0

                                 0

                                 0

                                 (b) Anti-tussives

                                 0

                                 0

                                 0

                                 (c) Medicines used for colds and sinusitis

                                 0

                                 0

                                 0

                                 1.7. Anti-infection

                                 (a) Antibiotics (at least two classes)

                                 0

                                 0

                                 0

                                 (b) Anti-parasitics

                                 0

                                 0

                                 0

                                 (c) Anti-tetanus vaccines and immunoglobulins

                                 0

                                 0

                                 0

                                 (d) Anti-malaria medicines, carriage shall be dependent upon operational area

                                 0

                                 0

                                 0

                                 1.8. Compounds promoting rehydration, caloric intake and plasma expansion

                                 0

                                 0

                                 0

                                 1.9. Medicines for external use

                                 (a) Skin medicines

                                 0

                                 0

                                 0

                                 — Antiseptic solutions

                                 0

                                 0

                                 0

                                 — Antibiotic ointments

                                 0

                                 0

                                 0

                                 — Anti-inflammatory and analgesic ointments

                                 0

                                 0

                                 0

                                 — Burn preparations

                                 0

                                 0

                                 0

                                 (b) Eye medicines

                                 0

                                 0

                                 0

                                 — Antibiotic and anti-inflammatory

                                 0

                                 0

                                 0

                                 — Anaesthetic drops

                                 0

                                 0

                                 0

                                 — Saline solution for eyewash

                                 0

                                 0

                                 0

                                 — Hypotonic myotic drops

                                 0

                                 0

                                 0

                                 (c) Ear medicines

                                 0

                                 0

                                 0

                                 — Anaesthetic and anti-inflammatory solutions

                                 0

                                 0

                                 0

                                 (d) Medicines for oral and throat infections

                                 0

                                 0

                                 0

                                 — Antiseptic mouthwashes

                                 0

                                 0

                                 0

                                 (e) Local anaesthetics

                                 0

                                 0

                                 0

                                 — Local anaesthetics given by subcutaneous injection

                                 0

                                 0

                                 0

                                 2. MEDICAL EQUIPMENT

                                 2.1 Resuscitation equipment

                                 — Ambu bag (or equivalent); supplied with large, medium and small masks

                                 0

                                 0

                                 0

                                 — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (3)

                                 0

                                 0

                                 0

                                 — Mechanical aspirator to clear upper respiratory passages

                                 0

                                 0

                                 0

                                 2.2. Dressing and suturing equipment

                                 — Tourniquets

                                 0

                                 0

                                 0

                                 — Disposable suture stapler or suture kit with needles

                                 0

                                 0

                                 0

                                 — Adhesive elastic bandage

                                 0

                                 0

                                 0

                                 — Gauze strips

                                 0

                                 0

                                 0

                                 — Sterile gauze compresses

                                 0

                                 0

                                 0

                                 — Sterile sheet for burns victims

                                 0

                                 0

                                 0

                                 — Triangular sling

                                 0

                                 0

                                 0

                                 — Disposable gloves

                                 0

                                 0

                                 0

                                 — Adhesive dressings

                                 0

                                 0

                                 0

                                 — Sterile compression bandages

                                 0

                                 0

                                 0

                                 — Adhesive sutures or zinc oxide bandages

                                 0

                                 0

                                 0

                                 — Vaseline gauze

                                 0

                                 0

                                 0

                                 2.3. Instruments

                                 — Instrument box made of suitable material

                                 0

                                 0

                                 0

                                 — Scissors

                                 0

                                 0

                                 0

                                 — Dissecting forceps

                                 0

                                 0

                                 0

                                 — Haemostatic clamps

                                 0

                                 0

                                 0

                                    2.4. Examination and monitoring equipment

                                 0

                                 0

                                 0

                                 — Disposable tongue depressors

                                 0

                                 0

                                 0

                                 — Medical evacuation sheets

                                 0

                                 0

                                 0

                                 — Stethoscope

                                 0

                                 0

                                 0

                                 — Sphygmomanometer

                                 0

                                 0

                                 0

                                 — Medical thermometer

                                 0

                                 0

                                 0

                                 — Hypothermic thermometer

                                 0

                                 0

                                 0

                                 —Quick malaria test, carriage shall be dependent upon operational area

                                 0

                                 0

                                 0

                                    2.5.
                                    Equipment for injection, perfusion, puncture and catheterisation

                                 0

                                 0

                                 0

                                 — Intravenous infusion set

                                 0

                                 0

                                 0

                                 — Disposable syringes and needles

                                 0

                                 0

                                 0

                                    2.6.
                                    General medical equipment

                                 0

                                 0

                                 0

                                 — Personal protective medical and nursing equipment

                                 0

                                 0

                                 0

                                    2.7.
                                    Immobilisation and setting equipment

                                 0

                                 0

                                 0

                                 — Set of splints of different sizes for the extremities

                                 0

                                 0

                                 0

                                 — Collar for neck immobilisation

                                 0

                                 0

                                 0

                                 3. ANTIDOTES

                                 3.1. General

                                 0

                                 0

                                 0

                                 3.2. Cardio-vascular

                                 0

                                 0

                                 0

                                 3.3. Gastro-intestinal system

                                 0

                                 0

                                 0

                                 3.4. Nervous system

                                 0

                                 0

                                 0

                                 3.5. Respiratory system

                                 0

                                 0

                                 0

                                 3.6. Anti-infective

                                 0

                                 0

                                 0

                                 3.7. For external use

                                 0

                                 0

                                 0

                                 3.8. Other

                                 0

                                 0

                                 0

                                 3.9. Necessary for the administration of oxygen (including maintenance requisites)

                                 0

                                 0

                                 0

                           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 required

                                 Quantities actually carried on board

                                 Remarks (in particular, any expiry date)

                                 1. MEDICINE

                                 1.1. Cardiovascular

                                 (a) Anti-angina preparations

                                 0

                                 0

                                 0

                                 1.2. Gastro-intestinal system

                                 (a) Anti-diarrhoeals

                                 0

                                 0

                                 0

                                 1.3. Analgesics and anti-spasmodics

                                 (a) Analgesics, anti-pyretics and anti-inflammatory preparations

                                 0

                                 0

                                 0

                                 1.4. Nervous system

                                 (c) Seasickness remedies

                                 0

                                 0

                                 0

                                 1.5. Medicines for external use

                                 (a) Skin medicines

                                 0

                                 0

                                 0

                                 — Antiseptic solutions

                                 0

                                 0

                                 0

                                 — Burn preparations

                                 0

                                 0

                                 0

                                 (b) Eye medicines

                                 0

                                 0

                                 0

                                 — Saline solution for eyewash

                                 0

                                 0

                                 0

                                 2. MEDICAL EQUIPMENT

                                 2.1. Dressing and suturing equipment

                                 — Tourniquets

                                 0

                                 0

                                 0

                                 — Adhesive elastic bandage

                                 0

                                 0

                                 0

                                 — Sterile gauze compresses

                                 0

                                 0

                                 0

                                 — Disposable gloves

                                 0

                                 0

                                 0

                                 — Adhesive dressings

                                 0

                                 0

                                 0

                                 — Sterile compression bandages

                                 0

                                 0

                                 0

                                 — Adhesive sutures or zinc oxide bandages

                                 0

                                 0

                                 0

                                 3. ANTIDOTES

                                 3.1. General

                                 0

                                 0

                                 0

                                 3.2. Cardio-vascular

                                 0

                                 0

                                 0

                                 3.3. Gastro-intestinal system

                                 0

                                 0

                                 0

                                 3.4. Nervous system

                                 0

                                 0

                                 0

                                 3.5. Respiratory system

                                 0

                                 0

                                 0

                                 3.6. Anti-infective

                                 0

                                 0

                                 0

                                 3.7. For external use

                                 0

                                 0

                                 0

                                 3.8. Other

                                 0

                                 0

                                 0

                                 3.9. Necessary for the administration of oxygen (including maintenance requisites)

                                 0

                                 0

                                 0

                           Venue and date: …
                     Captain’s signature: …
                     Authorisation by competent person or authority: …

               ’

               (1)  Under the conditions of use prescribed by national laws and/or practices

               (2)  Under the conditions of use prescribed by national laws and/or practices.

               (3)  Under the conditions of use prescribed by national laws and/or practices.


title: Commission Directive (EU) 2019/1258 of 23 July 2019 amending, for the purpose of its adaptation to technical progress, the Annex to Council Directive 80/181/EEC as regards the definitions of SI base units (Text with EEA relevance.)

text:
                  24.7.2019

                  EN

                  Official Journal of the European Union

                  L 196/6

         COMMISSION DIRECTIVE (EU) 2019/1258
         of 23 July 2019
         amending, for the purpose of its adaptation to technical progress, the Annex to Council Directive 80/181/EEC as regards the definitions of SI base units
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (1), in particular Article 16 thereof,
         Whereas:

                     (1)

                     Council Directive 80/181/EEC (2) defines the units of measurement to be used in the Union thus enabling to express measurements and indications of quantity in line with the International System of Units (SI), adopted by the General Conference on Weights and Measures (CGPM) set up by the Metre Convention signed in Paris on 20 May 1875.

                     (2)

                     Directive 2009/34/EC sets out the general framework for the adoption of separate Directives concerning, amongst others, measuring instruments and their technical requirements, units of measurement and the harmonisation of methods of measurement and metrological control. Article 16 of that Directive envisages that the Commission may amend the annexes to the separate Directives referred to in its Article 1 for the purpose of adaptation to technical progress, including Chapter I of the Annex to Directive 80/181/EEC.

                     (3)

                     The CGPM decided, at its 24th meeting in 2011, on a new way of defining the SI based on a set of seven defining constants drawn from the fundamental constants of physics and other constants of nature. This decision was confirmed at the 25th meeting of the CGPM in 2014.

                     (4)

                     On the 26th meeting of the CGPM in 2018, new definitions of the SI base units were adopted. The new definitions are based on the new principle of fixed numerical values of the defining constants and will be effective as from 20 May 2019. The new definitions are expected to improve the long-term stability and reliability of the SI base units as well as the accuracy and clarity of measurements.

                     (5)

                     The new definitions adopted by the CGPM reflect the latest developments in measurement science and standards. In order to adapt the definitions of the SI base units set out in Directive 80/181/EEC to technical progress and thus contribute to the uniform implementation of the SI, it is necessary to align them with the new definitions.

                     (6)

                     Directive 80/181/EEC should therefore be amended accordingly.

                     (7)

                     It is necessary to ensure that the new legislation applies as from the same date for all Member States, independently of the date of transposition, so that uniform implementation of Directive 80/181/EEC is in place.

                     (8)

                     The measures provided for in this Directive are in accordance with the opinion of the Committee for Adjustment to Technical Progress of the Directives referred to in Article 16 of Directive 2009/34/EC,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Amendment
            The Annex to Directive 80/181/EEC is amended in accordance with the Annex to this Directive.

            Article 2
            Transposition

               1.   Member States shall adopt and publish, by 13 May 2020 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
               They shall apply those provisions from 13 June 2020.
               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
            Entry into force
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            This Directive is addressed to the Member States.

            Done at Brussels, 23 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 106, 28.4.2009, p. 7.

            (2)  Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).

            ANNEX
            In the Annex, Chapter I, Section 1.1 is replaced by the following:

               ‘1.1.   SI base units

                           Quantity

                           Unit

                           Name

                           Symbol

                           Time

                           second

                           s

                           Length

                           metre

                           m

                           Mass

                           kilogram

                           kg

                           Electric current

                           ampere

                           A

                           Thermodynamic temperature

                           kelvin

                           K

                           Amount of substance

                           mole

                           mol

                           Luminous intensity

                           candela

                           cd

                     Definitions of SI base units:

                              Unit of time

                           The second, symbol s, is the SI unit of time. It is defined by taking the fixed numerical value of the caesium frequency Δν
                              Cs, the unperturbed ground-state hyperfine transition frequency of the caesium 133 atom, to be 9 192 631 770 when expressed in the unit Hz, which is equal to s– 1.

                              Unit of length

                           The metre, symbol m, is the SI unit of length. It is defined by taking the fixed numerical value of the speed of light in vacuum c to be 299 792 458 when expressed in the unit m/s, where the second is defined in terms of Δν
                              Cs.

                              Unit of mass

                           The kilogram, symbol kg, is the SI unit of mass. It is defined by taking the fixed numerical value of the Planck constant h to be 6,626 070 15 × 10– 34 when expressed in the unit J s, which is equal to kg m2 s– 1, where the metre and the second are defined in terms of c and Δν
                              Cs.

                              Unit of electric current

                           The ampere, symbol A, is the SI unit of electric current. It is defined by taking the fixed numerical value of the elementary charge e to be 1,602 176 634 × 10– 19 when expressed in the unit C, which is equal to A s, where the second is defined in terms of Δν
                              Cs.

                              Unit of thermodynamic temperature

                           The kelvin, symbol K, is the SI unit of thermodynamic temperature. It is defined by taking the fixed numerical value of the Boltzmann constant k to be 1,380 649 × 10– 23 when expressed in the unit J K– 1, which is equal to kg m2 s– 2 K– 1, where the kilogram, metre and second are defined in terms of h, c and Δν
                              Cs.

                              Unit of amount of substance

                           The mole, symbol mol, is the SI unit of amount of substance. One mole contains exactly 6,022 140 76 × 1023 elementary entities. This number is the fixed numerical value of the Avogadro constant, N
                              A, when expressed in the unit mol– 1 and is called the Avogadro number.
                           The amount of substance, symbol n, of a system is a measure of the number of specified elementary entities. An elementary entity may be an atom, a molecule, an ion, an electron, any other particle or specified group of particles.

                              Unit of luminous intensity

                           The candela, symbol cd, is the SI unit of luminous intensity in a given direction. It is defined by taking the fixed numerical value of the luminous efficacy of monochromatic radiation of frequency 540 × 1012 Hz, K
                              cd, to be 683 when expressed in the unit lm W– 1, which is equal to cd sr W– 1, or cd sr kg– 1 m– 2 s3, where the kilogram, metre and second are defined in terms of h, c and Δν
                              Cs.

                     1.1.1.   Special name and symbol of the SI derived unit of temperature for expressing Celsius temperature

                           Quantity

                           Unit

                           Name

                           Symbol

                           Celsius temperature

                           degree Celsius

                           °C

                     Celsius temperature t is defined as the difference t = T – T0
                   between the two thermodynamic temperatures T and T
                  0 where T
                  0 = 273,15 K. An interval or difference of temperature may be expressed either in kelvins or in degrees Celsius. The unit “degree Celsius” is equal to the unit “kelvin”.’


title: Commission Directive (EU) 2019/1929 of 19 November 2019 amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde (Text with EEA relevance)

text:
                  20.11.2019

                  EN

                  Official Journal of the European Union

                  L 299/51

         COMMISSION DIRECTIVE (EU) 2019/1929
         of 19 November 2019
         amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof,
         Whereas:

                     (1)

                     Directive 2009/48/EC establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2). Appendix C to Annex II to the Directive lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

                     (2)

                     Formaldehyde (CAS number 50-00-0) is currently not listed in Appendix C to Annex II to Directive 2009/48/EC. It is classified as carcinogenic category 1B under Regulation (EC) No 1272/2008. Pursuant to point 4(a) of Part III of Annex II to Directive 2009/48/EC, formaldehyde may be used up to a concentration of 0,1 %, which corresponds to 1 000 mg/kg (content limit).

                     (3)

                     In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission has established the Expert Group on Toys Safety (3). The mission of its subgroup Working group on Chemicals in Toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety with regard to chemical substances which may be used in toys.

                     (4)

                     Formaldehyde is used as a monomer in the manufacture of polymeric materials. Polymeric materials are often used in toys. Children may therefore ingest formaldehyde when mouthing toys containing polymeric materials. The tolerable daily intake (TDI) for formaldehyde was set by the World Health Organisation (WHO) (4) and has been confirmed by the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) of the European Food Safety Authority (5). The TDI is 0,15 mg/kg bodyweight per day. With an allocation of 10 % of the TDI to the intake of formaldehyde from toys (6); a child with a bodyweight of 10 kg should therefore not take in more than 0,15 mg formaldehyde per day. Assuming a daily ingestion of 100 ml of mouthing saliva, the subgroup Chemicals recommended, at its meeting on 26 September 2017 (7), a formaldehyde migration limit of 1,5 mg/l in polymeric materials when the migration of formaldehyde is determined in accordance with the test method in standards EN 71-10:2005 (8) and EN 71-11:2005 (9).

                     (5)

                     Formaldehyde is also used in the manufacture of resin-bonded wood products such as particle board, oriented-strand board (OSB), high-density fibre board (HDF), medium density fibre board (MDF) and plywood. Formaldehyde resins include phenol-formaldehyde (PF), urea-formaldehyde (UF), melamine-formaldehyde (MF) and polyacetal (polyoxymethylene — POM) resins. POM tends to be used only for small internal components and not in whole toys. The subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde emission limit of 0,1 ml/m3 when the emission of formaldehyde is determined in such materials in accordance with the test chamber method in standard EN 717-1:2004 (10). That limit corresponds to the indoor air limit value that the WHO has established to prevent sensory irritation in the general population and to prevent cancer (11).

                     (6)

                     Formaldehyde may also be present in textile toy material due to its use during the manufacture of textiles. According to a report from the Organisation for Economic Cooperation and Development (OECD) published in 2002, the lowest threshold concentration for allergic contact dermatitis from formaldehyde is 30 mg/kg (12). On that basis and in order to protect also the most sensitised individuals, the subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde content limit of 30 mg/kg when the content of formaldehyde is determined in accordance with the water extraction method in standard EN ISO 14184-1:2011 (13).

                     (7)

                     Formaldehyde may be present in leather toy material due to its use during the manufacture of leather. Since leather toy material may lead to an exposure similar to textile toy material the subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde content limit of 30 mg/kg when the content of formaldehyde is determined in accordance with standard EN ISO 17226-1:2008 (14).

                     (8)

                     Formaldehyde in paper toy material should have a content limit of 30 mg/kg according to the recommendation of the subgroup Chemicals at its meeting on 26 September 2017, when determined in accordance with the water extraction method in standard EN 645:1993 (15) and with standard EN 1541:2001 (16). That conclusion was based on the consideration that paper toy material may lead to an exposure similar to textile and leather toy material.

                     (9)

                     Formaldehyde may be present in water-based toy material due to its function as a preservative. It could be used in water-based toy materials such as soap bubbles or inks in felt-tip pens, and also in dry materials intended to be mixed with water prior to use. In light of the opinion of the Scientific Committee on Health and Environmental Risks (SCHER) that CMR compounds should not be present in toys (17), the subgroup Chemicals recommended, at its meeting on 3 May 2018 (18), a formaldehyde limit of 10 mg/kg in water-based toy material when the content of formaldehyde is determined according to the test method published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (the EDQM method) on the Determination of free formaldehyde in cosmetic products (19). The recommended limit is close to the lowest value that can be reliably determined by the EDQM method and takes account of traces of formaldehyde that certain other preservatives may release.

                     (10)

                     The Expert Group on Toys Safety took note, at is meeting on 19 December 2017 (20), of the recommendations of its subgroup Chemicals regarding the limits for formaldehyde in different toy materials. It expressed support and suggested a number of improvements for the Commission to consider.

                     (11)

                     Pursuant to Article 46(2) of Directive 2009/48/EC, the packaging requirements for food as laid down in Regulation (EC) No 1935/2004 are to be taken into account when adopting specific limit values for chemicals in Appendix C to that Directive The basic assumptions behind the specific migration limit for formaldehyde as a monomer in plastic food contact material (21) are, however, different from the basic assumptions behind the recommended migration limit for formaldehyde as a monomer in toys. Therefore, it is not possible to take account of the packaging requirements for food when setting a limit for formaldehyde as a monomer in toys.

                     (12)

                     In light of the available scientific evidence and the recommendations of the Expert Group on Toys Safety and its subgroup Chemicals, it is necessary to set the recommended limits for formaldehyde in different toy materials.

                     (13)

                     Appendix C to Annex II to Directive 2009/48/EC should therefore be amended accordingly.

                     (14)

                     The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee established under Article 47 of Directive 2009/48/EC,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            In Appendix C to Annex II to Directive 2009/48/EC, the following entry is added:

                        Substance

                        CAS No

                        Limit value

                        ‘Formaldehyde

                        50-00-0

                        1,5 mg/l (migration limit) in polymeric toy material
                        0,1 ml/m3 (emission limit) in resin-bonded wood toy material
                        30 mg/kg (content limit) in textile toy material
                        30 mg/kg (content limit) in leather toy material
                        30 mg/kg (content limit) in paper toy material
                        10 mg/kg (content limit) in water-based toy material’

            Article 2

               1.   Member States shall adopt and publish, by 20 May 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
               They shall apply those provisions from 21 May 2021.
               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, 19 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 170, 30.6.2009, p. 1.

            (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (3)  Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).
         http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360

            (4)  WHO (1993) Guidelines for drinking-water quality. Second Edition. World Health Organisation. Geneva. p. 98.

            (5)  https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2007.415. Referred to in the position paper of the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) for the subgroup Chemicals EXP/WG/2016/041.

            (6)  Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). Opinion on ‘Assessment of the bioavailability of certain elements in toys’. Adopted on 22 June 2004.
         http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf
         Scientific Committee on Health and Environmental Risks (SCHER). Opinion on ‘Risk from organic CMR substances in toys’. Adopted on 18 May 2010.
         Scientific Committee on Health and Environmental Risks (SCHER). Opinion on ‘Evaluation of the migration limits for chemical elements in Toys’. Adopted on 1 July 2010.

            (7)  Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’. http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=4151. The limit value was included in meeting document EXP/WG/2017/023.

            (8)  Safety of toys — Part 10: Organic chemical compounds – Sample preparation and extraction.

            (9)  Safety of toys — Part 11: Organic chemical compounds – Methods of analysis.

            (10)  Wood-based panels — Determination of formaldehyde release — Part 1: Formaldehyde emission by the chamber method.

            (11)  World Health Organisation (WHO) 2010, WHO guidelines for indoor air quality: selected pollutants. P. 140-142. http://www.euro.who.int/__data/assets/pdf_file/0009/128169/e94535.pdf

            (12)  EXP/WG/2016/058.

            (13)  Textiles — Determination of formaldehyde — Part 1: Free and hydrolysed formaldehyde (water extraction method) (ISO 14184-1:2011).

            (14)  Leather — Chemical determination of formaldehyde content – Part 1: Method using high performance liquid chromatography (ISO 17226-1:2008).

            (15)  Paper and board intended to come into contact with foodstuffs — Preparation of a cold water extract.

            (16)  Paper and board intended to come into contact with foodstuffs — Determination of formaldehyde in an aqueous extract.

            (17)  Scientific Committee on Health and Environmental Risks (SCHER). CEN’s response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys. Adopted on 29.5.2007.
         http://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_056.pdf

            (18)  Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’. http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=6870.

            (19)  https://www.edqm.eu/en/cosmetics-testing

            (20)  Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’.
         http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1485

            (21)  Entry 15 in Table 2 of Annex I of Regulation (EU) No 10/2011. OJ L 12, 15.1.2011, p. 1.