News


  • 23 April 2018 : The European Commission validates the BPC opinions and publishes the corresponding Legal acts :

    - COMMISSION IMPLEMENTING DECISION (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6

    - COMMISSION IMPLEMENTING REGULATION (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4

Additional information

PHMB overview

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> Information about CAS Registry Number of PHMB

Historically, PHMB was identified under several CAS-RN : 
91403-50-8 / 32289-58-0 / 27083-27-8.

91403-50-8 = PHMB in its hydrochloride form, single repeating unit with end groups (? + w) : 
-> Poly (imino carbonimidoyl imino carbonimidoyl imino-1,6-hexanediyl), alpha-(6-aminohexyl)-omega-(cyanoamino) iminométhyl] amino], hydrochloride (9 Cl)

32289-58-0 = PHMB in its hydrochloride form, single repeating unit without end groups
-> Poly(imino-carbonimidoyl-imino-carbonimidoyl-imino-1,6-hexanediyl), hydrochloride

27083-27-8 = PHMB descriptionbased on its manufacturing route polymer of “precursor-1” with “precursor-2” 
-> 1,6-hexanediamine, polymer with N,N’’’-1,6-hexanediylbis[N’-cyanoguanidine], hydrochloride

The exact definitions of each of these CAS-RN are found at Chemical Abstract Service (CAS) organisation or through specialised data bases or access suppliers.

 

March 2002 : PHMB was notified under CAS N° [91403-50-8which better described the active substance (this CAS describes the main repeating unit and its possible End Groups).

 

During year 2003 : CAS organization streamlined PHMB register in its DataBase and deleted CAS [91403-50-8] to merge it in the historically most elder CAS folder [32289-58-0]. Indeed, according to CAS rules, a substance must be described by only one CAS-RN. Therefore, CAS N° [91403-50-8] appears since then in the « DR » line (Deleted CAS Registry Number) of CAS N°[32289-58-0].

Note that a search on CASRN [91403-50-8] leads to CAS [32289-58-0].

 

From 2003 to 2015 : a confusion was possible between both sources of PHMB :

- Lonza’s PHMB was identified in the BPD/BPR process under both CAS [27083-27-8] and [32289-58-0]

- Paréva’s PHMB was identified in the BPD/BPR process under the only CAS [32289-58-0]

This confusion was most critical since the entering into force of the new classification for Lonza’s PHMB. 

 

August 2015 : CAS organization attributed a new CAS to Paréva’s PHMB : CAS [1802181-67-4]. Paréva’s PHMB was therefore identified as well by both CAS [32289-58-0] and [1802181-67-4].   

 

June 2016 : The PHMB eCA (France) issued the Competent Authority Report (CA-Report) on Paréva’s PHMB and precised that CAS [1802181-67-4] is the most appropriate.

 


> PHMB identification for the European Market

In order to better identify the different sources, authorities adopted a generic description for PHMB :

PHMB(Mn;PDI)

In which Mn is the mean number-average molecular weight and PDI is the PolyDispersity Index.

 

For Paréva source of PHMB, this identification is “PHMB(1415;4.7)”.