Bureau for Chemical Substance

The President of the Bureau for Chemical Substances is the competent authority for performing tasks relating to the registration laid down in Article 3(6) of Regulation (EC) No 273/2004 as well as the registration laid down in Article 7 of Regulation (EC) No 111/2005, including keeping the national register of operators and users who have been granted the registration, in accordance with Article 44 (4) of the Act of 29 July 2005 on prevention of drug addiction (Dz.U. of 2019 item 852, as amended).

Operators engaged in business activity involving drug precursors of category 2 are required, pursuant to Regulation (EC) 273/2004, to register this activity. This obligation also applies to users of precursors of Subcategory 2A and the operators that place precursors of Subcategory 2A and 2B on the market.

Operators established in the European Union, other than customs agents and transporters when acting solely in that capacity, engaged in import or export of substances scheduled and listed in the Annex under Category 2, or engaged in intermediary activities involving these substances, or engaged in export of substances listed in the Annex under Category 3 pursuant to Regulation (EC) No 111/2005, shall be registered. The registration is performed by the competent authorities of the member state in which the operator is established.  

Pursuant to Article 2(d) of Regulation (EC) No 111/2005 export means any departure of scheduled substances from the customs territory of the Union, including the departure of scheduled substances that requires a customs declaration and the departure of scheduled substances after their storage in a free zone of control type I or free warehouse within the meaning of Regulation (EEC) No 2913/92 establishing the Community Customs Code.

The registration is granted, refused to grant, suspended or cancelled in an administrative decision based on the operator’s application submitted to the President of the Bureau for Chemical Substances. The decision is made within 60 working days’ following the submission of complete application.

Registration procedure is laid down in Article 9 of Regulation (EU) 2015/1013, while the scope of the information required in the application is regulated in Article 3 of Regulation (EU) 2015/1011.

Applications for registration shall be submitted to the Bureau for Chemical Substances to the following address: Dowborczyków 30/34, 90-019 Łódź, Poland.

The proof of payment of the stamp duty shall be attached to the application for registration of drug precursors category 2 and 3.

The list of Precursors of Category 2 and threshold values:

	Substance	CN code	CAS	Threshold value
Subcategory 2A
1.	Acetic anhydride	2915 24 00	108-24-7	100 l
Subcategory 2B
2.	Phenylacetic acid	2916 34 00	103-82-2	1 kg
3.	Anthranilic acid	2922 43 00	118-92-3	1 kg
4.	Piperidine	2933 32 00	110-89-4	0,5 kg
5.	Potassium permanganate	2841 61 00	7722-64-7	100 kg
And the salts of the substances listed in this category, whenever the existence of such salts is possible.

PLEASE NOTE: The obligation to register is not applicable for users of subcategory 2B (i.e. the operators, who use these substances for their own needs and do not place them on the market) and the operators that operate below the above-listed threshold values (in the annual scale).

The list of Precursors of Category 3:

No.	Substance	CN designation (if different)	CN code	CAS	Threshold value
1.	Hydrochloric acid	Hydrogen chloride	2806 10 00	7647-01-0	100 kg
2.	Sulphuric acid		2807 00 10	7664-93-9	100 kg
3.	Toluene (1)		2902 30 00	108-88-3	50 kg
4.	Ethyl ether  (1)	Diethyl ether	2909 11 00	60-29-7	20 kg
5.	Acetone (1)		2914 11 00	67-64-1	50 kg
6.	Methylethylketone (1)	Butanone	2914 12 00	78-93-3	50 kg
) Including the salts of the substances listed in this category, whenever the existence of such salts is possible and not being the salts of hydrochloric acid and sulphuric acid.

PLEASE NOTE: Registration of export of substances scheduled under category 3 is not required if the total quantity of the substances exported by the operator within the previous calendar year (1 January – 31 December) has not exceeded the threshold value. 

Stamp duty for registration of drug precursors of Category 2 and 3

We kindly inform you that pursuant to Article 5 and 6 of the Act on stamp duty of 16 November 2006 (Dz.U. of 2016, item 1827), upon submission of the application for registration to operate using drug precursors of category 2 and 3, the applicant is required to pay a stamp duty. Pursuant to the annex to this Act (item 53) the stamp duty is 10 PLN, and it must be paid to a competent tax authority. Due to the location of our office, the Mayor of the City of Lodz performs the function of this authority.

More information is available HERE

 

Detergents

Detergent means any substance or preparation containing soaps and/or other surfactants intended for laundry washing, washing and cleaning processes. Detergents are marketed for use in households, or for institutional or industrial purposes

Requirements for detergents placed on the market in the European Union are laid down in Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents.

Text of this regulation in Polish is available HERE and in English HERE

President of the Bureau for Chemical Substances is the competent authority designated by virtue of Article 8 of Regulation (EC) No 648/2004 to perform administrative tasks in the field of detergents.

The list of competent authorities of the Member States designated by virtue of Article 8 of Regulation (EC) No 648/2004 is available HERE

Regulation (EC) No 648/2004 lays down:

• Requirements for detergents,
• Obligations of manufacturers of detergents.

It particularly lays down:

• criteria for the ultimate aerobic biodegradability of surfactants and detergents containing them,
• restrictions or bans on surfactants on grounds of biodegradability,
• derogations used in case where the criteria for the ultimate aerobic biodegradability have not been fulfilled,
• test methods for surfactants,
• restrictions in terms of the content of phosphates and other phosphorus compounds for detergents for consumers intended for laundry washing and detergents for consumers intended for automatic dishwashers,
• information which the manufacturer is required to store for competent authorities of a given member state and for medical personnel.

The labelling on the packaging of detergents shall contain:

• instructions for use and special precautions, for detergents sold to the general public intended to be used as laundry detergents, the information provided for in Annex VII B; address of the website with access to the ingredient datasheet in accordance with Annex VII D,
• dosage information (Annex VII B),
• information on the content of certain ingredients (Annex VIIA) (such as phosphates, anionic surfactants, cationic surfactants, amphoteric surfactants, non-ionic surfactants, oxygen-based bleaching agents),

• list of other constituents, such as enzymes, disinfectants, optical brighteners, perfumes,  preservation agents, allergenic perfume ingredients.

The manufacturer shall make available on a website the simplified ingredient datasheet.

The list of 26 allergens, which have to be labelled on the packaging of detergents, if they are added in the concentrations above 0,01% is available HERE

There have been issues with interpretation of Regulation (EC) 648/2004 therefore the European Commission has published a webpage with frequently asked questions and answers.

Document in English is available HERE