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1. ------IND- 2018 0186 PL- EN ------ 20180517 --- --- PROJET

Draft
Journal of Laws – 6 – Item 2227

Document signed by Marek Głuch Date: 2018.11.29 15:24:59 CEST

JOURNAL OF LAWS OF THE REPUBLIC OF POLAND OF THE REPUBLIC OF POLAND

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Warsaw, 29 November 2018
Item 2227

ACT

of [date] [month] 2018

on cosmetic products), ), )
of 4 October 2018

on cosmetic products1), ), )

Chapter 1


Article 2. For the purposes of this Act:

1) ‘serious undesirable effect’ – an undesirable effect attributable to the use of a cosmetic product, as referred to in Article 2(1)(p) of Regulation No 1223/2009;
1) ‘serious undesirable effect’ – a serious undesirable effect, as referred to in Article 2(1)(p) of Regulation No 1223/2009;

2) ‘good manufacturing practice’ – good manufacturing practice as referred to in Article 8 of Regulation No 1223/2009;

3) ‘distributor’ – a distributor referred to in Article 2(1)(e) of Regulation No 1223/2009;

4) ‘undesirable effect’ – an undesirable effect attributable to the use of a cosmetic product, as referred to in Article 2(1)(o) of Regulation No 1223/2009;

5) ‘packaging’ – all the processes, including filling and labelling, that a product mass must undergo to become a finished product;

6) ‘product mass’ – a cosmetic product that has gone through all the production stages up to the final stage of packaging, with the exception of said stage;
4) ‘undesirable effect’ – an undesirable effect, as referred to in Article 2(1)(o) of Regulation No 1223/2009;

5) ‘packaging’ – processes, including filling and labelling, that need to be performed to turn the product mass into the finished product;

6) ‘product mass’ – a cosmetic product that has undergone all the production stages up to the final stage of packaging, with the exception of said stage;

7) ‘responsible person’ – a responsible person referred to in Article 4 of Regulation No 1223/2009;


9) ‘cosmetic product’ – a cosmetic product referred to in Article 2(1)(a) of Regulation No 1223/2009;

10) ‘making available on the market’ – making a cosmetic product available on the market, as referred to in Article 2(1)(g) of Regulation No 1223/2009;
10) ‘making available on the market’ – making available on the market, as referred to in Article 2(1)(g) of Regulation No 1223/2009;

11) ‘end user’ – an end user referred to in Article 2(1)(f) of Regulation No 1223/2009;

12) ‘placing on the market’ – placing a cosmetic product on the market, as referred to in Article 2(1)(h) of Regulation No 1223/2009;
12) ‘placing on the market’ – placing on the market, as referred to in Article 2(1)(h) of Regulation No 1223/2009;

13) ‘manufacture of a cosmetic product’ – the processes leading to obtaining a finished product, including packaging, even if they do not take place on the same premises as the production of product mass;


Making cosmetic products available on the market and the manufacture thereof

Article 3. 1. The product information file referred to in Article 11(2) of Regulation No 1223/2009, made available in accordance with Article 11(3) of said Regulation, shall be drawn up in Polish or in English.

2. Part B of the cosmetic product safety report referred to in Article 10(1) of Regulation No 1223/2009, made available in accordance with Article 11(3) of said regulation, shall be drawn up in Polish.

Article 4. 1. Cosmetic products made available on the territory of the Republic of Poland shall be marked in Polish in line with the requirements referred to in Article 19 of Regulation No 1223/2009.

2. If a cosmetic product is not pre-packaged, is packaged at the point of sale at the purchaser's request, or is pre-packaged for immediate sale, the information referred to in Article 19(1) of Regulation No 1223/2009 shall be placed on the container or packaging in which the cosmetic product is exposed for sale.

Article 5. If the manufacturer is not the responsible person, they are obligated to designate a responsible person with the authorities referred to in Article 14.

Article 6. 1. The manufacturer is obligated to request that a plant manufacturing cosmetic products is entered in the list of such plants, hereinafter referred to as the ‘list of plants’.

2. The list of plants shall be managed by a county-level state sanitary inspectorate determined according to where the plant manufacturing cosmetic products has its headquarters.

3. The list of plants serves to monitor compliance with the principles of good manufacturing practices in line with Article 22 of Regulation No 1223/2009 and is not made available pursuant to the Act of 6 September 2001 on access to public information (Journal of Laws of 2016, item 1764; 2017, item 933).

4. A manufacturer shall submit a paper or electronic request for entry in the list of plants within 30 days after the onset of the activity in a plant manufacturing cosmetic products.

5. The request for entry in the list of plants shall include:

1) the name and surname or the name of the company and the address of the manufacturer;
Article 3. 1. The product information file referred to in Article 11(1) of Regulation No 1223/2009, made available in accordance with Article 11(3) of said Regulation, shall be drawn up in Polish or in English.

2. Part B of the cosmetic product safety report referred to in Article 10(1) of Regulation No 1223/2009, made available in accordance with Article 11(3) of said Regulation, shall be drawn up in Polish.

Article 4. 1. Cosmetic products made available on the territory of the Republic of Poland shall be marked in Polish.

2. If a cosmetic product is not pre-packaged, is packaged at the point of sale at the purchaser's request, or is pre-packaged for immediate sale, the information referred to in Article 19(1) of Regulation No 1223/2009 shall be placed on the container or packaging in which the cosmetic product was exposed for sale.

Article 5. Cosmetic products shall be placed on the market and made available on the market until the day of their date of minimum durability.

Article 6. 1. The list of plants manufacturing cosmetic products, hereinafter referred to as the ‘list of plants’, shall be managed by a county-level state sanitary inspectorate determined according to where the plant manufacturing cosmetic products has its headquarters.

2. The manufacturer issues to the body, referred to in paragraph 1, a request for entry of the plant manufacturing cosmetic products in the list of plants.

3. The list of plants serves to monitor compliance with the principles of good manufacturing practices in line with Article 22 of Regulation No 1223/2009 and is not made available pursuant to the Act of 6 September 2001 on access to public information (Journal of Laws 2018, items 1330 and 1669).

4. A manufacturer shall submit a paper or electronic request for entry in the list of plants within 30 days after the onset of the activity in a plant manufacturing cosmetic products.

5. The request for entry in the list of plants shall include:

1) the name and surname or the name of the company of the manufacturer and their/its address;

2) the name and address of the plant manufacturing cosmetic products;

3) the type and scope of activity to be carried out at the plant manufacturing cosmetic products.

6. An entry certificate shall be issued to the manufacturer, containing the date of entry in the list and the name and address of the plant manufacturing cosmetic products.

7. In the event of modification of the data referred to in paragraph 5, the manufacturer shall request such changes in the list of plants by submitting a paper or electronic request within 30 days after the change occurred. The request shall contain the data referred to in paragraph 5, which has been modified.

8. Removal from the list of plants shall be made on the basis of:
3) the type and scope of activity carried out at the plant manufacturing cosmetic products.

6. An entry certificate shall be issued to the manufacturer, containing the date of entry in the list and the name and address of the plant manufacturing cosmetic products.

7. In the event of modification of the data referred to in paragraph 5, the manufacturer shall request such changes in the list of plants by submitting a paper or electronic request within 30 days after the change occurred. The request shall contain the data referred to in paragraph 5, which has been modified.

8. Removal from the list of plants shall be made on the basis of:

1) a paper or electronic form submitted by a manufacturer requesting to remove a plant from the list, which shall contain the data referred to in paragraph 5;


3) information on the modification of the data referred to in Article 6(5) or the removal of a plant manufacturing cosmetic products from the list of plants.

2. The minister responsible for health shall set out, by way of a regulation, the models of:
2. The minister responsible for health shall set out, by way of a regulation, the models of:

1) the application form for entry in the list of plants,


4) the certificate of entry in the list of plants,

taking into account the scope of the data contained in the list of plants and ensuring the consistency of issued certificates.
taking into account the scope of the data contained in the list of plants and the need to ensure the consistency of issued certificates.

Chapter 3


Article 8. 1. A system for the communication of serious undesirable effects attributable to the use of cosmetic products is created and hereinafter referred to as the ‘system’.

2. The system serves to collect and store data on serious undesirable effects reported in accordance with Article 23 of Regulation No 1223/2009.

3. The Chief Sanitary Inspector is the controller of personal data and of the system.

4. To ensure data security during the system's operation, the Chief Sanitary Inspector entrusts the processing of the data contained within the system to an administrative centre set out in the provisions pursuant to Article 13.

5. The administrative centre shall meet the following requirements:
2. The system serves to process the data on serious undesirable effects reported in accordance with Article 23 of Regulation No 1223/2009.

3. The Chief Sanitary Inspector is the controller of personal data and of the system.

4. To ensure data security during the system's operation, the Chief Sanitary Inspector entrusts the processing of the data contained within the system to an administrative centre set out in the provisions pursuant to Article 13, hereinafter referred to as the ‘administrative centre’.

5. The administrative centre shall meet the following requirements:

1) has at least 5 years’ experience in the matters related to the process of assessing and classifying serious undesirable effects;


3) has experience in the matters related to the exposure to cosmetic products and chemical substances and mixtures;

4) employs persons qualified to assess and classify serious undesirable effects.

6. The administrative centre is obligated to create organisational and technical conditions ensuring the protection of the processed data against unauthorised access, illegal disclosure or acquisition, as well as the modification, corruption, destruction or loss thereof.

7. The Chief Sanitary Inspector may control the administrative centre with regard to the fulfilment of the conditions referred to in Article 6 and the manner in which the objectives are achieved with regard to the entrusted data processed in the system.

8. The administrative centre shall not entrust the processing of the data contained within the system to another entity.

9. The tasks of the administrative centre shall be financed from the part of the State budget governed by the minister responsible for health.

Article 9. 1. Information on serious undesirable effects shall be reported to the administrative centre.

2. Where a report of a serious undesirable effect to the administrative centre is made by an end user, it shall contain:

1) the name of a cosmetic product whose use is thought to have caused the undesirable effect, and the batch number thereof;
4) employs persons qualified to assess and classify serious undesirable effects;

5) creates organisational and technical conditions ensuring the protection of the processed data against unauthorised access, illegal disclosure or acquisition, as well as the modification, corruption, destruction or loss thereof.

6. The Chief Sanitary Inspector may control the administrative centre with regard to the fulfilment of the conditions referred to in paragraph 5(5) and the manner in which the objectives are achieved with regard to the entrusted data processed in the system.

7. The administrative centre shall not entrust the processing of the data contained within the system to another entity.

8. The tasks of the administrative centre shall be financed from the part of the State budget governed by the minister responsible for health.

Article 9. 1. Serious undesirable effects shall be reported to the administrative centre.

2. Where a report of a serious undesirable effect to the administrative centre is made by an end user, it shall contain:

1) the name of a cosmetic product whose use could have caused the serious undesirable effect, and the batch number thereof;

2) personal data of the user: