458/Sb.



GOVERNMENT REGULATION



of 18 May. December 2013



about the list of default and auxiliary substances and their annual quantitative

limits



Change: 242/2015 Sb.



The Government directs pursuant to § 53 para. 1 Act No. 272/Coll.

drug precursors:



§ 1



The list of default and auxiliary substances and their annual quantitative limits

are listed in the annex to this regulation.



§ 2



This regulation has been notified in accordance with the directive of the European Parliament

and Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision

information in the field of standards and technical regulations and rules on services,

the information society, as amended.



§ 3



The effectiveness of the



This Regulation shall enter into force on 1 January 2000. January 2014.



Prime Minister:



Samantha r in r.



Minister of health:



Holcat in r.



Annex



The list of default and auxiliary substances and their annual quantitative limits



+----------------------------+-------------------+-----------------------------+

| The default or excipient | CAS Number | Annual limit quantity (kg) |

+----------------------------+-------------------+-----------------------------+

| 1.4-Butanediol | 110-63-4 | 0 |

+----------------------------+-------------------+-----------------------------+

| Red phosphorus | 7723-14-0 | 0 |

+----------------------------+-------------------+-----------------------------+

| Gamma-butyrolactone | 96-48-0 | 0 |

+----------------------------+-------------------+-----------------------------+

| (1R, 2S)-(-)-Chlorefedrin | | |

including salt | 110925-64-9 apply | 0 |

| This substance | for hydrochloride | |

+----------------------------+-------------------+-----------------------------|

| (1S, 2R)-(+)-Chlorefedrin | 1384199-95-4 | |

| including the salts of the substances | applies to | 0 |

| | hydrochloride | |

+----------------------------+-------------------+-----------------------------|

| (1S,2S)-(+)- | 61-73393-0 applies | 0 |

| Chlorpseudoefedrin including | for hydrochloride | |

| salt of the substance | | |

+----------------------------+-------------------+-----------------------------|

| (1R,2R)-(-)- | 771434-80-1 | 0 |

| Chlorpseudoefedrin including | for hydrochloride | |

| salt of the substance | | |

+----------------------------+-------------------+-----------------------------+